Ipsen Initiates Partial Clinical Hold for Palovarotene IND120181 and IND135403 Studies
December 06 2019 - 1:00AM
Business Wire
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced, following
discussions with the U.S. Food and Drug Administration (FDA), that
a partial clinical hold effective immediately, for the pediatric
population under the age of 14 was issued for studies conducted
under IND120181 and IND135403 evaluating the investigational drug
candidate palovarotene for the chronic treatment of fibrodysplasia
ossificans progressiva (FOP) and multiple osteochondromas (MO),
respectively. The partial clinical hold applies to the pediatric
population (patients under the age of 14 years) currently
participating in the Phase 2 (PVO-1A-202/204 and PVO-2A-201) and
Phase 3 (PVO-1A-301) studies in all clinical sites at global level.
The FDA is allowing the studies to continue to treat patients 14
years of age and older.
The partial clinical hold was issued following recent safety
reports submitted by the company to the FDA of cases of early
growth plate closure in pediatric patients with FOP treated with
palovarotene. The FDA has placed the studies on partial clinical
hold pending review of additional details regarding these events
and plans to issue additional requests for information within the
next 30 days. Although no serious adverse events (SAEs) related to
early growth plate closure in the MO study have been reported to
date, this study has been included in this hold due to the
occurrence of these events with chronic dosing in the FOP program.
Since the MO study is a primarily pediatric study with the upper
age of enrollment at 14 years, all subjects currently participating
in the study will have interruption of treatment until further
notice and no new patients will be enrolled while the partial
clinical hold is in effect.
At Ipsen, the safety of patients is always a top priority, and
the company is committed to ensuring the safe and effective use of
its medicines. Ipsen is committed to researching and developing
therapies for children and adults living with FOP and MO, two rare
and devastating bone diseases with no current therapeutic treatment
options.
Ipsen is committed to working diligently with the FDA to provide
all requested information with the goal of resolving the partial
clinical hold. Ipsen continues to prepare the FDA New Drug
Application (NDA) filing for palovarotene in acute/flare-up
FOP.
About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group
focused on innovation and Specialty Care. The Group develops and
commercializes innovative medicines in three key therapeutic areas
– Oncology, Neuroscience and Rare Diseases. Its commitment to
oncology is exemplified through its growing portfolio of key
therapies for prostate cancer, neuroendocrine tumors, renal cell
carcinoma and pancreatic cancer. Ipsen also has a well-established
Consumer Healthcare business. With total sales over €2.2 billion in
2018, Ipsen sells more than 20 drugs in over 115 countries, with a
direct commercial presence in more than 30 countries. Ipsen’s
R&D is focused on its innovative and differentiated
technological platforms located in the heart of the leading
biotechnological and life sciences hubs (Paris-Saclay, France;
Oxford, UK; Cambridge, US). The Group has about 5,800 employees
worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the
United States through a Sponsored Level I American Depositary
Receipt program (ADR: IPSEY). For more information on Ipsen, visit
www.ipsen.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20191205005981/en/
Media Christian Marcoux, M.Sc. Senior Vice President,
Global Communications +33 (0)1 58 33 67 94
Christian.marcoux@ipsen.com
Karla MacDonald Vice President, Communications, North America +1
(857) 332-3467 Karla.macdonald@ipsen.com Financial Community
Eugenia Litz Vice President, Investor Relations +44 (0) 1753 627721
eugenia.litz@ipsen.com Myriam Koutchinsky Investor Relations
Manager +33 (0)1 58 33 51 04 myriam.koutchinsky@ipsen.com
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