Inspiration, Ipsen receive FDA Fast Track designation for OBI-1 to treat AHA

Published on November 20, 2012 at 3:19 AM · No Comments

Ipsen (Euronext: IPN, ADR: IPSEY) (Paris:IPN) and Inspiration Biopharmaceuticals Inc. (Inspiration) today announced that Inspiration has received Fast Track designation from the US Food and Drug Administration (FDA) for OBI-1 in acquired hemophilia A. OBI-1, an intravenous recombinant porcine factor VIII (FVIII), is being evaluated for the treatment of individuals with acquired hemophilia A, who have developed inhibitory antibodies (inhibitors) against their innate FVIII.

Fast track is a designation that the FDA reserves for a drug intended to treat a serious disease and has a potential to fill an unmet medical need. Fast track designation is designed to facilitate the development and expedite the review of new drugs. Marketing applications for fast track development programs are likely to be considered appropriate for priority review, which implies an abbreviated review time of eight months. Inspiration intends to submit a biologics license application (BLA) to FDA in the first half of 2013.

OBI-1 received Orphan Drug Designation from the FDA in March 2004 and from the European Medicines Agency (EMA) in October 2010.

Source:

Ipsen

Read in | English | Español | Français | Deutsch | Português | Italiano | 日本語 | 한국어 | 简体中文 | 繁體中文 | Nederlands | Русский | Svenska | Polski
Comments
The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
Post a new comment
Post
You might also like... ×
Researchers discover new therapeutic approach for hemophilia