More data on dosing needed for Flutiform
This article was originally published in Pharmaceutical Approvals Monthly
SkyePharma receives a 74-day letter from FDA for its asthma treatment Flutiform (fluticasone/formoterol inhalation aerosol), noting that although its NDA is "sufficiently complete," based on FDA's preliminary assessment it is "likely" that further clinical work would be required for approval - specifically to accumulate additional data on dosing. SkyePharma is seeking further clarification of review issues. Flutiform is a fixed-dose combination of formoterol and the inhaled steroid fluticasone in a metered dose inhaler. The U.K.-based drug delivery company is partnering with Abbott in the U.S. and Mundipharma in the EU, where Flutiform is expected to be filed for approval in the first quarter of 2010. The application was submitted to FDA in March 2009 and accepted May 22, 2009
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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)
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