AstraZeneca/Abbott's combo cholesterol drug Certraid in doubt after FDA calls for more information

Anglo-Swedish drug major AstraZeneca and the USA's Abbott Laboratories announced yesterday that the US Food and Drug Administration issued a complete response letter for the New Drug Application for Certriad (rosuvastatin/fenofibric) acid delayed release capsules for the treatment of elevated cholesterol levels. The news sent out worrying signals, and the UK-headquartered firm saw its share price dip 1.3% to £29.42 shortly after the news.

The combination drug, which the two firms are jointly developing, was first filed with the FDA last summer, supported by data from multiple studies, including efficacy and safety studies with the 5mg, 10mg and 20mg doses of rosuvastatin, the active ingredient of AstraZeneca's blockbuster cholesterol lowerer Crestor which generated fourth-quarter 2009 sales of $1.26 billion, combined with fenofibric acid, which is sold by Abbott as TriLipix (The Pharma Letter June 5).Given that it finally receives marketing approval, Certriad has been projected as having an annual sales potential of $500 million.

The companies say they are currently evaluating the CRL, will continue discussions with the FDA to determine next steps with respect to the Certriad NDA and will respond to the agency's request for additional information.