Recordati Rare Diseases is now the holder of the European marketing authorization for Isturisa® (osylodrostat) indicated for adult patients with endogenous Cushing’s syndrome
Paris, April 8, 2020 – Recordati Rare Diseases today announces the transfer of the European marketing authorization from Isturisa® (Osilodrostat). The transfer includes all EU member states as well as the UK, Norway, Iceland and Liechtenstein.
Isturisa® it is authorized for the treatment of adult patients with Cushing’s syndrome. Isturisa® is a powerful inhibitor of 11β-hydroxylase (CYP11B1), the enzyme responsible for the final phase of cortisol biosynthesis1. Isturisa® has demonstrated rapid and prolonged normalization of cortisol levels in a significant percentage of adult patients with a manageable safety profile, making it a new oral treatment option for patients with Cushing’s syndrome2, 3
Cushing’s syndrome is an endocrine disease caused by an excess of cortisol, a vital hormone that regulates metabolism, maintains cardiovascular function and helps the body respond to stress. It is a rare but serious disease that most commonly affects adults aged 20 to 50 and affects women three times more often than men. It can present with weight gain, central obesity, a round, full red face, severe fatigue and weakness, striae (purple stretch marks), hypertension, depression and anxiety. Cushing’s syndrome can cause serious illness and death with mortality up to four times higher than in the healthy population4, 5, 6.
” Isturisa® (osilodrostat) is a new and important treatment option in the management of patients with Cushing’s syndrome, a rare serious, potentially life-threatening disease, “said Rosario Pivonello, MD, Professor in the Department of Molecular and Clinical Endocrinology and Oncology Federico II University of Naples, Italy. “Cushing’s syndrome involves an increased risk of cardiovascular and cerebrovascular diseases, as well as hypercoagulability, diabetes, infections, depression and a reduction in the quality of life. If not properly treated, Cushing’s syndrome has an increased mortality. The primary goal of treatment is the normalization of cortisol levels. Up to now, patients have had few approved options, with limited efficacy or with too many adverse effects. With this new oral treatment, having demonstrated efficacy and safety from a long-term perspective, we have a therapeutic option that will help meet the needs of patients in this poorly served patient population. “
In the pivotal phase 3 LINC-3 study, a significantly higher percentage of Cushing’s disease patients treated with Isturisa® maintained normal normal urinary free cortisol (mUFC) at the end of the 8-week randomized withdrawal period (week 34) compared to placebo (86% vs 29%). Controlling the cortisol level is the main goal in the treatment of patients with Cushing’s disease. Adverse drug reactions associated with Isturisa® and occurring in over 20% of patients are adrenal insufficiency, fatigue, nausea, headache and edema.7
“As a company with a strong commitment to rare diseases, we are excited to provide Isturisa®, an effective therapeutic option for patients with Cushing’s syndrome, “said Massimo Mineo, EMEA Director General.” Rare pituitary disorders, such as Cushing and the unmet needs of patients with this special subset of diseases, are at the heart of our efforts. in endocrinology. Today, April 8, is Cushing’s day of awareness. In memory of Harvey Cushing, who first described the syndrome in 1932, we would like to draw attention to the importance of improving awareness and encouraging accurate and early diagnosis of Cushing’s syndrome and other rare pituitary diseases. “
The European Commission has granted Isturisa® a European marketing authorization as an orphan drug. Recordati Rare Diseases plans to market for the third quarter of 2020.
Recordati Rare Diseases, part of the Recordati group, recently started an endocrinology business unit and is actively building its commercial, medical and market access teams. The company is developing a global distribution model that will support patients and healthcare professionals.
1. Bertagna X et al. J Clin Endocrinol Metab 2014; 99: 1375–83.
2. Fleseriu M et al. Pituitary 2016; 19: 138–48.
3. Biller BMK et al. Extract OR16-2. Oral presentation at the Endocrine Society Annual Congress 2019.
4. Nieman LK. Endocrinol Metab 2018; 33: 139–46.
5. Lonser RR et al. J Neurosurg 2017; 126: 404
6. Dekkers O et al J Clin Endocrinol Metab, 2013, 98 (6): 2277-84
7. Summary of the characteristics of the Isturisa® product. January 2020.
Recordati, founded in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of over 4,300, dedicated to research, development, production and marketing of products. pharmaceuticals. Based in Milan, Italy, Recordati operates throughout Europe, including Russia, Turkey, North Africa, the United States of America, Canada, Mexico, some countries in South America, Japan and Australia. An efficient field strength of medical representatives promotes a wide range of innovative pharmaceutical products, both proprietary and licensed, in a number of therapeutic areas, including a specialized business dedicated to treatments for rare diseases. Recordati is the partner of choice for the licensing of new products for its territories. Recordati is engaged in the research and development of new specialties with particular attention to cures for rare diseases. Consolidated revenues for 2019 were 1,481.8 million euros, operating profit was 465.3 million euros and net profit of 368.9 million euros.
For more information:
Recordati Rare Diseases website: www.recordatirarediseases.com
International Marketing Manager
Gordon J Daniels
(33) 0.607.531,337 thousand
e-mail: [email protected]
The statements contained in this release, other than historical facts, are “forward-looking statements” (as this term is defined in the Private Securities Litigation Reform Act of 1995). These statements are based on currently available information, best current estimates and reasonable assumptions. This information, these estimates and assumptions may prove incomplete or incorrect and involve numerous risks and uncertainties, beyond the control of the Company. Therefore, actual results may differ materially from those expressed or implied by such forward-looking statements. All mentions and descriptions of Recordati products are intended solely as information on the general nature of the company’s activities and are not intended to indicate the opportunity to administer any product in a particular case.
RRD now holds the Isturisa European MA