Today in London the FDA decided to postpone approval of a new experimental heart drug, seeking more information about the new product.
According to Rueters,
The manufacturers said on Tuesday they had received a so-called “complete response letter” from the U.S. Food and Drug Administration for Certriad, which combines Astra’s blockbuster cholesterol pill Crestor and Abbott’s TriLipix.
Both companies said they were evaluating the letter from the agency and would respond to the request for additional information. An AstraZeneca spokesman declined to give further details.
In typical big pharma fashion, Astra did not disclose what the FDA has a problem with, but many analysts have voiced concern that Certraid does not have enough backing to pass FDA approval after the results from a clinical study this month showed there was no real benefit from adding TriLipix to Crestor.