Market Overview

Gentium Requests Re-Examination of Negative CHMP Opinion on Defibrotide

Share:

Gentium S.p.A. (NASDAQ: GENT) (the "Company") today announced that it has requested a re-examination of the negative opinion adopted, by the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP"), on March 22nd, regarding the Marketing Authorisation (MAA) submitted for Defibrotide to treat and prevent hepatic veno-occlusive disease ("VOD") in adults and children undergoing hematopoietic stem cell transplantation therapy.

In accordance with European regulations, the Company has 60 days to submit grounds for appeal and the CHMP has further 60 days to consider a revision of the initial opinion. The appeal involves a re-examination of the original MAA and must be based on the data already submitted.

Notwithstanding the CHMP's negative opinion, Gentium remains convinced of the favourable benefit/risk profile of Defibrotide, which is the only option recommended by the European Group for Blood and Marrow Transplantation for the treatment VOD, an unmet medical need where no agents are currently approved.

EU patients will continue to have access to Defibrotide, under a named patient program ("NPP") where available.

The European Group for Blood and Marrow Transplantation (EBMT) have also commented on the CHMP's recommendation not to grant a marketing authorization; www.ebmt.org.

About VOD

Veno-occlusive

See full press release

Posted-In: News Guidance Contracts Global

 

Related Articles (GENT)

View Comments and Join the Discussion!
Need corporate guidance data?
Click here to see licensing options.
Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Trading Daily
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Daily Analyst Rating
A summary of each day’s top rating changes from sell-side analysts on the street.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at vipaccounts@benzinga.com

Fluor Awarded Clean Fuels Contract by South African Petroleum Refineries

Benzinga Market Primer: Tuesday, April 16