European approval for Mundipharma/SkyePharma's asthma drug Flutiform

After some delays, the European Commission has now adopted a legally binding decision in favor of granting of marketing authorizations for Flutiform (fluticasone propionate/formoterol fumarate), a new combination therapy for the maintenance treatment of asthma, in Europe. The drug will be marketed in Europe by Swiss privately-held Mundipharma.

This decision follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (The Pharma Letter April 22). The European Commission decision is binding and the 21 member states in the decentralized procedure are now required to grant national marketing authorisations or approvals consistent with the decision. Timings of these will be dependent on negotiations with the national regulatory and, where relevant, reimbursement authorities.

Product uses SkyePharma technology