SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation -- Ignore unavailable to you. Want to Upgrade?


To: scaram(o)uche who wrote (342)2/20/2003 9:05:20 AM
From: scaram(o)uche  Respond to of 631
 
LFA3tip not approved, CPMP................

European Approval of AMEVIVE(R) Delayed
Thursday February 20, 8:11 am ET
Committee Requests Additional Clinical Information

CAMBRIDGE, Mass., Feb. 20 /PRNewswire-FirstCall/-- Biogen, Inc. (Nasdaq: BGEN - News) announced today that the Committee for Proprietary Medicinal Products (CPMP), the scientific advisory body of the European Medicines Evaluation Agency (EMEA), requested more information relating to its application for AMEVIVE® (alefacept) for psoriasis. In the final assessment received this week, the CPMP determined that more clinical information is needed to approve the product. Biogen has withdrawn its application and plans to develop the additional clinical information necessary to obtain approval of AMEVIVE for psoriasis patients in Europe. Developing the data and re-filing the application to gain approval could take several years.

(snip)