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Recordati's Isturisa is expected to launch in the second or third quarter. (Getty) As part of a small 2019 deal, Italian drugmaker Recordati snagged a trio of underperforming Novartis endocrinology meds, including a late-stage candidate for Cushing's disease. Less than a year later, that drug is cleared for market after an FDA green light. The FDA on Friday approved Recordati's Isturisa (osilodrostat) to treat Cushing's disease—a rare disease in which patients' adrenal glands produce too much cortisol—in those who have undergone a prior pituitary gland surgery or are not eligible for one. Isturisa, a cortisol synthesis inhibitor, will come with the FDA's orphan drug designation, providing market exclusivity for seven years, Recordati said (PDF) in a release. The drug is expected to be commercially available in the second or third quarter. The FDA based its review on phase 3 data showing 86% of patients treated with Isturisa showed normal cortisol levels in their urine after eight weeks, compared with 29% of patients treated with placebo, the drugmaker said. Recordati is "actively building its commercial, medical, and market access teams" to accommodate Isturisa's launch through its recently created U.S. endocrinology business unit, it said. The drugmaker will launch the drug with a "comprehensive distribution model" through specialty pharmacies. Novartis, once the owner of Isturisa, turned the asset over to Recordati in 2019 as part of a $390 million offload of some of the Swiss drugmaker's endocrinology portfolio. Recordati received Signifor, long-acting sister Signifor LAR and Isturisa, positioned as a successor drug to Signifor. The purchase included milestone payments tied to Isturisa. Recordati talked up the buy of the Cushing's disease trio as a boon for its rare disease portfolio, calling it a "key and historical milestone" at the time. From https://www.fiercepharma.com/pharma/recordati-scores-fda-nod-for-cushing-s-disease-med-isturisa -
I don't know if there's anything of interest here - or the cost - but possibly useful to someone. Cushing’s Syndrome Diagnostic and Treatment Market research report is the new statistical data source added by Research Cognizance. “Cushing’s Syndrome Diagnostic and Treatment Market is growing at a High CAGR during the forecast period 2022-2029. The increasing interest of the individuals in this industry is that the major reason for the expansion of this market”. Cushing’s Syndrome Diagnostic and Treatment Market research is an intelligence report with meticulous efforts undertaken to study the right and valuable information. The data which has been looked upon is done considering both, the existing top players and the upcoming competitors. Business strategies of the key players and the new entering market industries are studied in detail. Well explained SWOT analysis, revenue share, and contact information are shared in this report analysis. Get the PDF Sample Copy (Including FULL TOC, Graphs, and Tables) of this report @: https://researchcognizance.com/sample-request/896 Top Key Players Profiled in this report are: Novartis, Orphagen Pharmaceuticals, Inc., Corcept Therapeutics The key questions answered in this report: What will be the Market Size and Growth Rate in the forecast year? What are the Key Factors driving Cushing’s Syndrome Diagnostic and Treatment Market? What are the Risks and Challenges in front of the market? Who are the Key Vendors in Cushing’s Syndrome Diagnostic and Treatment Market? What are the Trending Factors influencing the market shares? What are the Key Outcomes of Porter’s five forces model? Which are the Global Opportunities for Expanding the Cushing’s Syndrome Diagnostic and Treatment Market? Various factors are responsible for the market’s growth trajectory, which are studied at length in the report. In addition, the report lists down the restraints that are posing threat to the global Cushing’s Syndrome Diagnostic and Treatment market. It also gauges the bargaining power of suppliers and buyers, threat from new entrants and product substitute, and the degree of competition prevailing in the market. The influence of the latest government guidelines is also analyzed in detail in the report. It studies the Cushing’s Syndrome Diagnostic and Treatment market’s trajectory between forecast periods. Get up to 30% Discount on this Premium Report @: https://researchcognizance.com/discount/896 Regions Covered in the Global Cushing’s Syndrome Diagnostic and Treatment Market Report 2022: • The Middle East and Africa (GCC Countries and Egypt) • North America (the United States, Mexico, and Canada) • South America (Brazil etc.) • Europe (Turkey, Germany, Russia UK, Italy, France, etc.) • Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia) The cost analysis of the Global Cushing’s Syndrome Diagnostic and Treatment Market has been performed while keeping in view manufacturing expenses, labor cost, and raw materials and their market concentration rate, suppliers, and price trend. Other factors such as Supply chain, downstream buyers, and sourcing strategy have been assessed to provide a complete and in-depth view of the market. Buyers of the report will also be exposed to a study on market positioning with factors such as target client, brand strategy, and price strategy taken into consideration. The report provides insights on the following pointers: Market Penetration: Comprehensive information on the product portfolios of the top players in the Cushing’s Syndrome Diagnostic and Treatment market. Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and product launches in the market. Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market. Market Development: Comprehensive information about emerging markets. This report analyzes the market for various segments across geographies. Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Cushing’s Syndrome Diagnostic and Treatment market. Table of Content Global Cushing’s Syndrome Diagnostic and Treatment Market Research Report Chapter 1: Global Cushing’s Syndrome Diagnostic and Treatment Industry Overview Chapter 2: Global Economic Impact on Cushing’s Syndrome Diagnostic and Treatment Industry Chapter 3: Global Market Competition by Industry Producers Chapter 4: Global Productions, Revenue (Value), according to regions Chapter 5: Global Supplies (Production), Consumption, Export, Import, geographically Chapter 6: Global Productions, Revenue (Value), Price Trend, Product Type Chapter 7: Global Market Analysis, on the basis of Application Chapter 8: Cushing’s Syndrome Diagnostic and Treatment Market Pricing Analysis Chapter 9: Market Chain, Sourcing Strategy, and Downstream Buyers Chapter 10: Strategies and key policies by Distributors/Suppliers/Traders Chapter 11: Key Marketing Strategy Analysis, by Market Vendors Chapter 12: Market Effect Factors Analysis Chapter 13: Global Cushing’s Syndrome Diagnostic and Treatment Market Forecast Buy Exclusive Report @: https://researchcognizance.com/checkout/896/single_user_license If you have any special requirements, please let us know and we will offer you the report as you want. About Us: Research Cognizance is an India-based market research Company, registered in Pune. Research Cognizance aims to provide meticulously researched insights into the market. We offer high-quality consulting services to our clients and help them understand prevailing market opportunities. Our database presents ample statistics and thoroughly analyzed explanations at an affordable price. Contact Us: Neil Thomas 116 West 23rd Street 4th Floor New York City, New York 10011 sales@researchcognizance.com +1 7187154714
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Cushing’s disease is a progressive pituitary disorder in which there is an excess of cortisol in the body. While the disease can be treated surgically, this option is not possible for all patients. This is one of the approved medications that assist in controlling cortisol levels in people with Cushing’s disease. sturisa was approved in 2020 to treat adults with Cushing’s disease for whom pituitary surgery is ineffective or not an option. The oral medication works by inhibiting an enzyme called 11-beta-hydroxylase, which is involved in cortisol production. Isturisa, also known as osilodrostat or LCI699, is an approved treatment originally developed by Novartis, but now acquired by Recordati to treat people with Cushing’s disease, a condition in which a pituitary tumor causes the body to produce excessive levels of the stress hormone cortisol. In 2020, the U.S. Food and Drug Administration (FDA) approved Isturisa to treat adults with Cushing’s disease for whom pituitary surgery was not an option, or ineffective. Earlier that same year, the European Commission (EC) approved Isturisa to treat people with endogenous Cushing’s syndrome. The medication also was approved for the same indication in Japan in 2021. How does Isturisa work? Isturisa is an oral medicine that inhibits an enzyme called 11-beta-hydroxylase, which is involved in cortisol production. Blocking the activity of this enzyme prevents excessive cortisol production, normalizing the levels of the hormone in the body and easing the symptoms of Cushing’s disease. Isturisa in clinical trials A Phase 2 clinical trial (NCT01331239) investigated the safety and efficacy of Isturisa as a Cushing’s disease treatment. The trial that concluded in October 2019 initially was named LINC-1, but, through a study protocol amendment, patients who completed the study could continue into a second phase called LINC-2. The company published findings that covered both patient groups in the journal Pituitary. Data showed that Isturisa reduced cortisol levels in the urine of all patients by week 22. Urine cortisol levels reached and remained within a normal range in 79% of the patients by then. Common adverse effects included nausea, diarrhea, lack of energy, and adrenal insufficiency — a condition in which the adrenal glands are unable to produce enough hormones. A Phase 3 clinical trial (NCT02180217) called LINC-3 also assessed the safety and efficacy of Isturisa in 137 patients with Cushing’s disease (77% female, median age 40 years). Participants were given Isturisa for 26 weeks, with efficacy-based dose adjustments during the first 12 weeks. Then, the 71 participants with a complete response (those whose urine cortisol levels were within normal limits) at week 26 and who did not require a dose increase after week 12, were assigned randomly to either continue treatment with Isturisa or switch to a placebo. After this 34-week period, 86% of Isturisa-treated patients had normal urinary cortisol levels, as compared to 29% of participants given placebo. All participants then were given Isturisa for an additional 12 weeks. At the end of the 48-week study, 66% of participants had normal urine cortisol levels. Results from LINC-3 formed the basis for regulatory approvals of Isturisa. Common adverse side effects in the trial included nausea, headache, fatigue, and adrenal insufficiency. A multi-center, randomized, double-blind, placebo-controlled Phase 3 trial (NCT02697734) called LINC-4 further confirmed the safety and efficacy of Isturisa as a Cushing’s disease therapy. During the trial, patients received Isturisa or a placebo through a 12-week period followed by treatment with Isturisa until week 48. Top-line results showed that 77% of patients on Isturisa experienced a complete response after the 12-week randomized period, as compared to 8% of those on placebo. No new safety data were noted. A roll-over, worldwide Phase 2 study (NCT03606408) is recruiting patients who have successfully completed any of the previous clinical trials. Patients can continue to take the dosage they received during the initial trial. The aim of this study is to assess the long-term effects of Isturisa for up to five years.
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Cushing disease is caused by tumour in the pituitary gland which leads to excessive secretion of a hormone called adrenocorticotrophic (ACTH), which in turn leads to increasing levels of cortisol in the body. Cortisol is a steroid hormone released by the adrenal glands and helps the body to deal with injury or infection. Increasing levels of cortisol increases the blood sugar and can even cause diabetes mellitus. However the disease is also caused due to excess production of hypothalamus corticotropin releasing hormone (CRH) which stimulates the synthesis of cortisol by the adrenal glands. The condition is named after Harvey Cushing, the doctor who first identified the disease in 1912. Cushing disease results in Cushing syndrome. Cushing syndrome is a group of signs and symptoms developed due to prolonged exposure to cortisol. Signs and symptoms of Cushing syndrome includes hypertension, abdominal obesity, muscle weakness, headache, fragile skin, acne, thin arms and legs, red stretch marks on stomach, fluid retention or swelling, excess body and facial hair, weight gain, acne, buffalo hump, tiredness, fatigue, brittle bones, low back pain, moon shaped face etc. Symptoms vary from individual to individual depending upon the disease duration, age and gender of the patient. Get Sample Copy of this Report @ https://www.persistencemarketresearch.com/samples/14155 Disease diagnosis is done by measuring levels of cortisol in patient’s urine, saliva or blood. For confirming the diagnosis, a blood test for ACTH is performed. The first-line treatment of the disease is through surgical resection of ACTH-secreting pituitary adenoma, however disease management is also done through medications, Cushing disease treatment market comprises of the drugs designed for lowering the level of cortisol in the body. Thus patients suffering from Cushing disease are prescribed medications such as ketoconazole, mitotane, aminoglutethimide metyrapone, mifepristone, etomidate and pasireotide. Cushing’s disease treatment market revenue is growing with a stable growth rate, this is attributed to increasing number of pipeline drugs. Also increasing interest of pharmaceutical companies to develop Cushing disease drugs is a major factor contributing to the revenue growth of Cushing disease treatment market over the forecast period. Current and emerging players’ focuses on physician education and awareness regarding availability of different drugs for curing Cushing disease, thus increasing the referral speeds, time to diagnosis and volume of diagnosed Cushing disease individuals. Growing healthcare expenditure and increasing awareness regarding Cushing syndrome aids in the revenue growth of Cushing’s disease treatment market. Increasing number of new product launches also drives the market for Cushing’s disease Treatment devices. However availability of alternative therapies for curing Cushing syndrome is expected to hamper the growth of the Cushing’s disease treatment market over the forecast period. For entire list of market players, request for Table of content here @ https://www.persistencemarketresearch.com/toc/14155 The Cushing’s disease Treatment market is segment based on the product type, technology type and end user Cushing’s disease Treatment market is segmented into following types: By Drug Type Ketoconazole Mitotane Aminoglutethimide Metyrapone Mifepristone Etomidate Pasireotide By End User Hospital Pharmacies Retail Pharmacies Drug Stores Clinics e-Commerce/Online Pharmacies Cushing’s disease treatment market revenue is expected to grow at a good growth rate, over the forecast period. The market is anticipated to perform well in the near future due to increasing awareness regarding the condition. Also the market is anticipated to grow with a fastest CAGR over the forecast period, attributed to increasing investment in R&D and increasing number of new product launches which is estimated to drive the revenue growth of Cushing’s disease treatment market over the forecast period. Depending on geographic region, the Cushing’s disease treatment market is segmented into five key regions: North America, Latin America, Europe, Asia Pacific (APAC) and Middle East & Africa (MEA). North America is occupying the largest regional market share in the global Cushing’s disease treatment market owing to the presence of more number of market players, high awareness levels regarding Cushing syndrome. Healthcare expenditure and relatively larger number of R&D exercises pertaining to drug manufacturing and marketing activities in the region. Also Europe is expected to perform well in the near future due to increasing prevalence of the condition in the region. Asia Pacific is expected to grow at the fastest CAGR because of increase in the number of people showing the symptoms of Cushing syndrome, thus boosting the market growth of Cushing’s disease treatment market throughout the forecast period. Some players of Cushing’s disease Treatment market includes CORCEPT THERAPEUTICS, HRA Pharma, Strongbridge Biopharma plc, Novartis AG, etc. However there are numerous companies producing branded generics for Cushing disease. The companies in Cushing’s disease treatment market are increasingly engaged in strategic partnerships, collaborations and promotional activities to capture a greater pie of market share. The research report presents a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, and statistically supported and industry-validated market data. It also contains projections using a suitable set of assumptions and methodologies. The research report provides analysis and information according to categories such as market segments, geographies, types, technology and applications.
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Cushing syndrome, a rare endocrine disorder caused by abnormally excessive amounts of the hormone cortisol, has a new pharmaceutical treatment to treat cortisol overproduction. Osilodrostat (Isturisa) is the first FDA approved drug who either can’t undergo pituitary gland surgery or have undergone the surgery but still have the disease. The oral tablet functions by blocking the enzyme responsible for cortisol synthesis, 11-beta-hydroxylase. “Until now, patients in need of medications…have had few approved options, either with limited efficacy or with too many adverse effects. With this demonstrated effective oral treatment, we have a therapeutic option that will help address patients' needs in this underserved patient population," said Maria Fleseriu, MD, FACE, professor of medicine and neurological surgery and director of the Pituitary Center at Oregon Health Sciences University. Cushing disease is caused by a pituitary tumor that releases too much of the hormone that stimulates cortisol production, adrenocorticotropin. This causes excessive levels of cortisol, a hormone responsible for helping to maintain blood sugar levels, regulate metabolism, help reduce inflammation, assist in memory formulation, and support fetus development during pregnancy. The condition is most common among adults aged 30-50 and affects women 3 times more than men. Cushing disease can lead to a number of medical issues including high blood pressure, obesity, type 2 diabetes, blood clots in the arms and legs, bone loss and fractures, a weakened immune system, and depression. Patients with Cushing disease may also have thin arms and legs, a round red full face, increased fat around the neck, easy bruising, striae (purple stretch marks), or weak muscles. Side effects of osilodrostat occurring in more than 20% of patients are adrenal insufficiency, headache, nausea, fatigue, and edema. Other side effects can include vomiting, hypocortisolism (low cortisol levels), QTc prolongation (heart rhythm condition), elevations in adrenal hormone precursors (inactive substance converted into hormone), and androgens (hormone that regulated male characteristics). Osilodrostat’s safety and effectiveness was evaluated in a study consisting of 137 patients, of which about 75% were women. After a 24-week period, about half of patients had achieved normal cortisol levels; 71 successful cases then entered an 8-week, double-blind, randomized withdrawal study where 86% of patients receiving osilodrostat maintained normal cortisol levels, compared with 30% who were taking a placebo. In January 2020, the European Commission also granted marketing authorization for osilodrostat. From https://www.ajmc.com/newsroom/patients-with-cushing-have-new-nonsurgical-treatment-option
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The U.S. Food and Drug Administration today approved Isturisa (osilodrostat) oral tablets for adults with Cushing's disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease. Cushing's disease is a rare disease in which the adrenal glands make too much of the cortisol hormone. Isturisa is the first FDA-approved drug to directly address this cortisol overproduction by blocking the enzyme known as 11-beta-hydroxylase and preventing cortisol synthesis. "The FDA supports the development of safe and effective treatments for rare diseases, and this new therapy can help people with Cushing's disease, a rare condition where excessive cortisol production puts them at risk for other medical issues," said Mary Thanh Hai, M.D., acting director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research. "By helping patients achieve normal cortisol levels, this medication is an important treatment option for adults with Cushing's disease." Cushing's disease is caused by a pituitary tumor that releases too much of a hormone called adrenocorticotropin, which stimulates the adrenal gland to produce an excessive amount of cortisol. The disease is most common among adults between the ages of 30 to 50, and it affects women three times more often than men. Cushing's disease can cause significant health issues, such as high blood pressure, obesity, type 2 diabetes, blood clots in the legs and lungs, bone loss and fractures, a weakened immune system and depression. Patients may have thin arms and legs, a round red full face, increased fat around the neck, easy bruising, striae (purple stretch marks) and weak muscles. Isturisa's safety and effectiveness for treating Cushing's disease among adults was evaluated in a study of 137 adult patients (about three-quarters women) with a mean age of 41 years. The majority of patients either had undergone pituitary surgery that did not cure Cushing's disease or were not surgical candidates. In the 24-week, single-arm, open-label period, all patients received a starting dose of 2 milligrams (mg) of Isturisa twice a day that could be increased every two weeks up to 30 mg twice a day. At the end of this 24-week period, about half of patients had cortisol levels within normal limits. After this point, 71 patients who did not need further dose increases and tolerated the drug for the last 12 weeks entered an eight-week, double-blind, randomized withdrawal study where they either received Isturisa or a placebo (inactive treatment). At the end of this withdrawal period, 86% of patients receiving Isturisa maintained cortisol levels within normal limits compared to 30% of patients taking the placebo. The most common side effects reported in the clinical trial for Isturisa were adrenal insufficiency, headache, vomiting, nausea, fatigue and edema (swelling caused by fluid retention). Hypocortisolism (low cortisol levels), QTc prolongation (a heart rhythm condition) and elevations in adrenal hormone precursors (inactive substance converted into a hormone) and androgens (hormone that regulates male characteristics) may also occur in people taking Isturisa. Isturisa is taken by mouth twice a day, in the morning and evening as directed by a health care provider. After treatment has started, a provider may re-evaluate dosage, depending upon the patient's response. Isturisa received Orphan Drug Designation, which is a special status granted to a drug intended to treat a rare disease or condition. The FDA granted the approval of Isturisa to Novartis. Media Contact: Monique Richards, 240-402-3014 Consumer Inquiries: Email, 888-INFO-FDA The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. SOURCE U.S. Food and Drug Administration Related Links http://www.fda.gov From https://www.prnewswire.com/news-releases/fda-approves-new-treatment-for-adults-with-cushings-disease-301019293.html
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November 7, 2012 The US Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously in support of the use of Signifor® (pasireotide) for the treatment of patients with Cushing's disease who require medical therapeutic intervention. The recommendation was based on data from clinical trials of pasireotide, including PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease), the largest randomized Phase III study to evaluate a medical therapy in patients with Cushing's disease. Patient Assistance for SIGNIFOR support for patients includes: - Therapy-specific support programs for out-of-pocket costs - Alternative assistance searches and referrals to Federal and State assistance programs - Referrals to Independent Charitable Foundations for assistance with co-pay costs - Patient assistance for low-income and uninsured patients For more information, or to speak to a Patient Assistance NOW Endocrinology representative, please call 1-877-503-3377 (select option #3 for SIGNIFOR) Monday to Friday 8 am - 8 pm ET.
