FDA rejects Merck’s Arcoxia

Share this article:
The FDA has issued a non-approvable letter for Merck’s Arcoxia. Merck was seeking approval of the Vioxx-like drug as a treatment for osteoarthritis. Vioxx was pulled off the market in September 2004 after being linked to an increased risk of heart attack and stroke in patients taking the drug. Arcoxia had been under review by the FDA as an investigational selective COX-2 inhibitor since the NDA was submitted in December 2003 for a 60 mg once-daily dose along with review of a separate related NDA for a 30 mg once-daily dose submitted in April 2004. In its non-approvable letter, the FDA indicated the drugmaker would need to provide additional data in support of the benefit-to-risk profile for the proposed doses of Arcoxia in order to gain approval. “We are disappointed” with the decision, said Peter Kim, president, Merck Research Laboratories. Arcoxia is currently marketed in 63 other countries. Pfizer’s Celebrex is the only COX-2 currently available on the US market.
Share this article:
close

Next Article in News

Email Newsletters

More in News

BMS Q2 sales slip, Eliquis, Yervoy soar

BMS Q2 sales slip, Eliquis, Yervoy soar

The company attributed part of the Eliquis boost to the BMS-Pfizer DTC and education efforts.

Gilead, Merck HCV marketing battle may be on horizon

Gilead, Merck HCV marketing battle may be on ...

Disclosed in its earnings report yesterday, Gilead may have a card up its sleeve to counter Merck's experimental hep. C combo regimen.

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.