The EMA’s Committee for Medicinal Products for Human Use (“CHMP”) has issued a positive opinion on SkyePharma’s MAA for its flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of asthma. The MAA had been referred to CHMP after the concerned member states failed to reach consensus on the application.
According to SkyePharma, the company expects the remainder of the standing committee process to take about 2-3 months, plus 1-3 months for national approvals by the concerned member states and time for negotiations with authorities regarding pricing and reimbursement in some of the countries. Mundipharma, which will market and distribute flutiform in Europe, plans to launch the product as soon as those procedures are complete.
SkyePharma CEO Peter Grant commented, “The positive opinion of the CHMP is an important step forward for the development of flutiform and we look forward to receiving the final decision from the EMA in due course. This is a strong endorsement of our capabilities in developing innovative and complex respiratory products like flutiform. It is also good news that we are now on track for a new treatment option to be available for many patients suffering from asthma across Europe.”
Read the SkyePharma press release.
