FDA rejects Merck's Cordaptive

Share this article:
The FDA has issued Merck a not approvable letter regarding its developmental cholesterol-lowerer dubbed Cordaptive.

Regulators have also rejected the brand name of Cordaptive for the drug, which is also known as Mk-0524a. The drug is a combination of good-cholesterol raising vitamin niacin and laropiprant, a drug designed to lessen the facial flushing caused by niacin.

Merck said it plans to meet with the agency to provide additional data and further examine the drug's benefit-risk profile. 

Merck planned to package Cordaptive with its treatment Zocor, a $5 billion-a-year blockbuster before losing patent protection in 2006.

The failure of Cordaptive “comes as a surprise, given the publicly disclosed data,'' said Deutsche Bank analyst Barbara Ryan in a note to investors today. “Without more information, it is difficult to gauge what the FDA took issue with, or what additional data Merck could provide to gain approval.”
Share this article:

Email Newsletters

More in News

Sales of Biogen MS pill pick up overseas

Sales of Biogen MS pill pick up overseas

Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.

GSK second-quarter sales disappoint

GSK second-quarter sales disappoint

Executives urge analysts to focus on the company's long-term potential.

House bill would speed approval once EU OKs same product

House bill would speed approval once EU OKs ...

The Speeding Access to Already Approved Pharmaceuticals Act of 2014 would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union