Complete response letter on Cladribine tablets issued by FDA

If it's on your mind and it has to do with multiple sclerosis in any way, post it here.

Complete response letter on Cladribine tablets issued by FDA

Postby MSUK » Wed Mar 02, 2011 12:48 am

Image

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) on the new drug application (NDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for relapsing-remitting multiple sclerosis (MS).

A complete response letter is issued by the FDA when the Agency's review of a file is complete and the application cannot be approved in its present form. In the complete response letter, the FDA concluded that substantial evidence of Cladribine Tablets' effectiveness was provided by the CLARITY(1)study. However, the FDA has requested the Company provide an improved understanding of safety risks and the overall benefit-risk profile either through additional analyses or by additional studies. EMD Serono intends to request an end-of-review meeting with the FDA to clarify next steps and to identify whether data from completed and ongoing clinical studies can address the Agency's questions.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... geid/1629/
MS-UK - http://www.ms-uk.org/
User avatar
MSUK
Family Elder
 
Posts: 2211
Joined: Wed Oct 14, 2009 2:00 pm

Advertisement

Re: Complete response letter on Cladribine tablets issued by

Postby HarryZ » Wed Mar 02, 2011 7:37 am

Sounds like the FDA is being far more cautious with the side effect issue after the fiasco of quickly approving Tysabri a few years ago.

Harry
User avatar
HarryZ
Family Elder
 
Posts: 2557
Joined: Tue May 25, 2004 2:00 pm
Location: London, ON, Canada


Return to General Discussion

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users


Contact us | Terms of Service