Future of Skyepharma's combination asthma therapy Flutiform is up in the air in the U.S.
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Drug delivery specialist SkyePharma issued a statement June 24 saying it is reviewing available options for advancing its asthma therapy Flutiform (fluticasone/formoterol) in the U.S. "It is apparent that the FDA's requirements for approving Flutiform have changed materially during the course of the development program," the company said. FDA told the company in June 2009 that further clinical studies likely would be required for approval and followed up in January with a "complete response" letter (1Pharmaceutical Approvals Monthly, June 1, 2009). Meanwhile, an application to market the asthma drug in Europe, "where the regulatory approach is different," was filed in March and is under review. SkyePharma is partnered with Abbott on the inhaler in the U.S. and with Mundipharma in the EU; Flutiform is in Phase II studies with partner Kyorin in Japan. The U.K.-based company focused on Flutiform in the U.S. after a formoterol inhaler partnered with Novartis gained approval but never went to market because of safety concerns related to single agent inhalers (2"The Pink Sheet," Dec. 22. 2008)