News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Arena Pharmaceuticals, Inc. (ARNA) Responds to FDA Worries About Antiobesity Drug


1/4/2012 8:25:22 AM

Arena Pharmaceuticals and partner Eisai are hopeful regulators will look kindly on its obesity drug lorcaserin after responding to a rejection issued by the US Food and Drug Administration in October 2010. Arena has submitted its reply to the complete response letter from the FDA which cited a number of reasons for its decision, notably concerns about tumours found in animal studies. The response includes data and analyses that were not incorporated in the original New Drug Application, including the results of the Phase III BLOOM-DM trial, which evaluated lorcaserin for weight loss in patients with type 2 diabetes.

Read at Pharma Times [Free Reg Req'd]
Read at CBS News
Read at Reuters
Read at Nasdaq
Read at Wall Street Journal

comments powered by Disqus
   
Obesity

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES