Data from the Phase III LINC-3 study, published in Lancet
Diabetes & Endocrinology, demonstrate that Isturisa®
(osilodrostat) rapidly decreases mean urinary free cortisol (mUFC)
in patients with Cushing’s disease.
Recordati Rare Diseases announces today that Lancet Diabetes
& Endocrinology has published positive results from the Phase
III LINC-3 pivotal study of Isturisa®, recently approved for the
treatment of endogenous Cushing’s syndrome in adults. Patients with
Cushing’s disease, the most common form of endogenous Cushing’s
syndrome, have an increased risk of significant comorbidities,
including cardiovascular and cerebrovascular diseases as a result
of excessive cortisol levels.1 Data from the large LINC-3 study,
which enrolled 137 patients with Cushing’s disease, demonstrate
that Isturisa® rapidly reduces mUFC and sustains this reduction
alongside improvements in comorbidities, clinical signs and
patients’ quality of life over 48 weeks.
“The exciting data, published today, underscore the efficacy and
safety of Isturisa® in a prospective setting, and represent a
significant advance for the management of patients with Cushing’s
disease, a serious and potentially life-threatening rare
condition,” said Rosario Pivonello, MD, Professor of Endocrinology
at the Federico II University of Naples, Italy. “I would like to
thank all the patients who participated in the LINC-3 study, and
their families, who have helped to bring this new and welcome
treatment option to this underserved patient population.”
The LINC-3 study met its primary endpoint, with significantly
more patients maintaining normal mUFC with Isturisa® without a dose
increase than placebo (86% vs 29%; P<0.0001) following 8 weeks
of randomized withdrawal (week 34). Further analysis of patients’
mUFC response found:
- Over half (53%) of patients achieved the key secondary endpoint
of a normal mUFC after an initial 24 weeks of open-label treatment
with Isturisa®, without any dose increase after week 12
- Majority (72%) of patients had normal mUFC at week 12, and
two-thirds (66%) of patients had normal mUFC at the end of the
48-week study
- Almost all (96%) patients achieved normal mUFC at some point
during the study, with a median time to first complete response of
41 days
Decreases in mUFC levels during treatment with Isturisa® were
accompanied by improvements in clinical signs and
cardiovascular-related risk factors (weight, BMI, blood glucose,
blood pressure, and total cholesterol). Isturisa® is well
tolerated, with the most common adverse effects in LINC-3 being
nausea (42%), headache (34%), fatigue (28%) and adrenal
insufficiency (28%).
“The publication of these data in Lancet Diabetes &
Endocrinology confirms Isturisa® as an effective new treatment
option for patients with Cushing’s syndrome,” said Andrea
Recordati, CEO. “Following the recent approval of Isturisa® in the
US and EU, we are excited to bring Isturisa® to all of those
patients who need it.”
The full manuscript can be accessed online at:
http://www.thelancet.com/journals/landia/article/PIIS2213-8587(20)30240-0/fulltext
About Cushing’s syndrome Cushing’s syndrome is caused by
an inappropriate and chronic exposure to excessive levels of
cortisol. The source of this excess of cortisol can be endogenous
or exogenous (ie medication).2 When the excess cortisol production
is triggered by a pituitary adenoma (ie. a tumor of the pituitary
gland located in the brain) secreting excess adrenocorticotropic
hormone (ACTH), the condition of the patient is defined as
Cushing’s disease and comprises about 70% of Cushing’s syndrome
cases.2,3 It is a rare, serious and difficult-to-treat disease that
affects approximately one to two patients per million per year.
Prolonged exposure to elevated cortisol levels is associated with
considerable morbidity, mortality and impaired quality of life as a
result of complications and comorbidities.4 Normalization of
cortisol levels is therefore a primary objective in the treatment
of Cushing’s syndrome.5
About LINC-3 LINC-3 is a prospective, multicentre,
48-week trial with an 8-week, double-blind, randomized withdrawal
phase to evaluate the safety and efficacy of Isturisa® in patients
with Cushing’s disease. The primary endpoint in the LINC-3 trial is
the proportion of patients randomized to Isturisa® and placebo,
separately, at Week 26 with a mUFC ≤ULN at the end of the 8-week
randomized withdrawal period (Week 34), without a dose increase
during this period. The key secondary endpoint is the proportion of
enrolled patients with a mUFC ≤ULN after an initial 24 weeks of
open-label treatment with Isturisa® without any dose increase after
Week 12. LINC-3 involved 137 patients with persistent or recurrent
Cushing’s disease or those with de novo disease who were not
candidates for surgery.1
About Isturisa® Isturisa® is a potent oral inhibitor of
11β-hydroxylase (CYP11B1), the enzyme that catalyses the final step
of cortisol biosynthesis in the adrenal gland. Isturisa® is
available as 1 mg, 5 mg and 10 mg film-coated tablets. Isturisa®,
indicated for the treatment of adult patients with endogenous
Cushing’s syndrome, is now available in France as the first EU
country to launch. Isturisa® was granted marketing authorization by
the European Commission on 9 January 2020. Please see prescribing
information for detailed recommendations for the use of this
product.6
- Pivonello R et al. Lancet Diabetes Endocrinol 2020; doi:
10.1016/S2213-8587(20)30240-0 [Epub ahead of print]
- Lacroix A et al. Lancet 2015;386:913–27
- Nieman LK et al. Am J Med 2005;118:1340–6
- Pivonello R et al. Lancet Diabetes Endocrinol
2016;4:611–29
- Nieman LK et al. J Clin Endocrinol Metab 2015;100:2807–31
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Isturisa® Summary of Product Characteristics, May 2020
About Recordati Rare Diseases The company’s EMEA
headquarters is located in Puteaux, France, with global headquarter
offices located in Milan, Italy.
For a full list of products, please click here:
www.recordatirarediseases.com/products.
About the Recordati group 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 additional information, please visit our websites:
www.recordati.com and https://www.recordatirarediseases.com/ or
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version on businesswire.com: https://www.businesswire.com/news/home/20200727005863/en/
Gordon J Daniels Head of International Marketing Telephone: +33
(0)607531337 e-mail: daniels.g@recordati.com
Recordati (BIT:REC)
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