The European Commission (EC) has approved SkyePharma’s flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of asthma in the 21 European countries using the decentralized procedure. The CHMP issued a positive opinion for flutiform in April 2012 after the 21 member states had failed to reach a consensus in late 2011.
The company says that it expects the first national approvals by the end of 2012 depending on the timing of negotiations with national regulatory and reimbursement authorities. Mundipharma will distribute the product in Europe.
SkyePharma CEO Peter Grant said, “The European Commission’s positive decision on flutiform is excellent news for the Company and we look forward to launches across Europe in the second half of this year. To get a product of this complexity through to approval has been an immense achievement by SkyePharma and our partner Mundipharma. It is also a strong endorsement of the Group’s capabilities in developing innovative and complex respiratory products and good news that a new treatment option will be available for many patients suffering from asthma across Europe.”
“Asthma is a debilitating condition which affects millions of people across Europe, and its symptoms are still not optimally controlled. We are very pleased that we can now obtain approvals in 21 countries in Europe and continue to plan for launch as soon as possible following the issuance of national marketing authorizations,” commented Mundipharma Regional Director Europe, Antony Mattessich.
Read the SkyePharma press release.
Read the Mundipharma press release.
