Recordati Rare Diseases now holds Isturisa® European MA
Recordati Rare Diseases is now the European Marketing
Authorization holder of Isturisa® (osilodrostat) indicated for
Adult patients with Endogenous Cushing’s
Syndrome
Paris, 8 April, 2020 – Recordati Rare Diseases
today announces the transfer of the European Marketing
Authorization of Isturisa® (osilodrostat). The transfer includes
all EU member states plus the UK, Norway, Iceland and
Liechtenstein.
Isturisa® is authorized for the treatment of
adult patients with Cushing’s syndrome. Isturisa® is a potent
inhibitor of 11β-hydroxylase (CYP11B1), the enzyme responsible for
the final step of cortisol biosynthesis1. Isturisa® has
demonstrated rapid and sustained normalization of cortisol levels
in a significant proportion of adult patients with a manageable
safety profile, making this a novel oral treatment option for
patients with Cushing's syndrome2, 3
Cushing's syndrome is an endocrine disorder
caused by excessive 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 as young as 20 to 50 years and
affects women three times more often than men. It may present with
weight gain, central obesity, a round, red full face, severe
fatigue and weakness, striae (purple stretch marks), high blood
pressure, depression and anxiety. Cushing's syndrome can cause
severe illness and death with mortality up to four times higher
than in the healthy population4, 5, 6.
‘‘Isturisa® (osilodrostat) is an important and
welcome new treatment option in the management of patients with
Cushing’s syndrome, a severe, potentially life-threatening rare
disease,” said Rosario Pivonello, M.D., Professor at the Department
of Molecular and Clinical Endocrinology and Oncology of the
Frederico II University of Naples, Italy. “Cushing’s syndrome
results in an increased risk of cardiovascular and cerebrovascular
diseases, as well as hypercoagulability, diabetes, infections,
depression, and decreased quality of life. If not
appropriately treated, Cushing’s syndrome has increased mortality.
The primary treatment goal is the normalization of cortisol levels.
Until now, patients have had few approved options, either with
limited efficacy or with too many adverse effects. With this new
oral treatment, having shown efficacy and safety in a prospective
long-term setting, we have a therapeutic option that will help
address patients’ needs in this underserved patient
population.”
In the phase 3 pivotal LINC-3 study, a
significantly higher proportion of patients with Cushing’s disease
treated with Isturisa® maintained normal mean urinary free cortisol
(mUFC) at the end of the 8‐week randomized withdrawal period (week
34) versus placebo (86% vs 29%). Cortisol level control is the
primary objective in the treatment of patients with Cushing’s
disease. Adverse drug reactions associated with Isturisa® and
occurring in greater than 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
treatment option to patients with Cushing’s Syndrome”, said Mr
Massimo Mineo, General Manager EMEA. “Rare pituitary disorders,
like Cushing’s and the unmet needs of patients with this special
subset of diseases, are at the heart of our efforts in
endocrinology. Today, April 8th, is Cushing’s Awareness day. 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 granted Isturisa® a
European Marketing Authorisation as an Orphan Drug. Recordati Rare
Diseases expects commercialisation to initiate in Q3 2020.
Recordati Rare Diseases, part of the Recordati
group, recently launched an endocrinology business unit and is
actively building its commercial, medical, and market access teams.
The company is developing a comprehensive distribution model that
will support patients and healthcare providers.
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.
Abstract 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;126:4046. Dekkers O et al J Clin
Endocrinol Metab, 2013, 98(6):2277-847. Isturisa® Summary of
Product Characteristics. January 2020.
Recordati, established 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 more than 4,300, dedicated to the research,
development, manufacturing and marketing of pharmaceuticals.
Headquartered in Milan, Italy, Recordati has operations throughout
the whole of Europe, including Russia, Turkey, North Africa, the
United States of America, Canada, Mexico, some South American
countries, Japan and Australia. An efficient field force of
medical representatives promotes a wide range of innovative
pharmaceuticals, both proprietary and under license, in a number of
therapeutic areas including a specialized business dedicated to
treatments for rare diseases. Recordati is a partner of choice for
new product licenses for its territories. Recordati is committed to
the research and development of new specialties with a focus on
treatments for rare diseases. Consolidated revenue for 2019
was € 1,481.8 million, operating income was € 465.3 million and net
income was € 368.9 million.
For further information: Recordati Rare Diseases
website: www.recordatirarediseases.comHead of International
Marketing
Gordon J
Daniels
(33)0607531337
e-mail:
daniels.g@recordati.com
Statements contained in this release, other than historical facts,
are "forward-looking statements" (as such term is defined in the
Private Securities Litigation Reform Act of 1995). These statements
are based on currently available information, on current best
estimates, and on assumptions believed to be reasonable. This
information, these estimates and assumptions may prove to be
incomplete or erroneous, and involve numerous risks and
uncertainties, beyond the Company’s control. Hence, 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 advisability of administering any product in any
particular instance.
- RRD now holds Isturisa European MA
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