Today in London the FDA decided to postpone approval of a new experimental heart drug, seeking more information about the new product.
The drug called Certriad, combines AstraZeneca’s blockbuster cholesterol pill Crestor with Abbott Laboratories TriLipix.
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.
Combo pills are fairly common for heart drugs, and most thought that FDA approval was a given. Merck merged Zocor and Zetia to form Vytorin, and soon they plan to combine Zetia with Pfizer’s Lipitor.
Combo pills are also fairly common in diabetes drugs. For example Januvia, Avandia,and Actos are all available as combo product with generic versions Glucophage.
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.
