Press Release

Ipsen statement on updated timeline for palovarotene FDA Advisory Committee meeting

PARIS, FRANCE, 25 October 2022 – Ipsen (Euronext: IPN; ADR: IPSEY) reports that the U.S. Food and Drug Administration (FDA) has today announced its decision to postpone the planned Endocrinologic and Metabolic Drugs Advisory Committee meeting for investigational palovarotene until a later date to be confirmed. The original advisory committee meeting was scheduled for 31 October 2022. The FDA informed Ipsen that the postponement relates to an FDA request for new information on palovarotene clinical trial data and does not relate to the safety profile of palovarotene. The company is currently working to fulfil the request. We will work expediently with the FDA as we remain committed to bringing innovative treatment options to the fibrodysplasia ossificans progressiva community.

 

About Ipsen 

Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With Specialty Care sales of €2.6bn in FY 2021, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,000 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com

 

For further information:

Contacts

 

Investors

 Craig Marks

Vice President, Investor Relations

+44 (0)7584 349 193

Adrien Dupin de Saint-Cyr

Investor Relations Manager

+33 6 64 26 17 49

Media

Anna Gibbins

Global Head of Franchise Communications, Rare Disease

+44 7717801900

Rachel Reiff

U.S. Head of Franchise Communications
+1 908 616 1680

 

 

 

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