Thursday, April 26, 2012

Mundipharma receives CHMP positive opinion for LABA/ICS combination - Flutiform

After a long battle, Flutiform (Fluticasone +formotorol)  has finally received a positive recommendation from the EU CHMP for the treatment of Asthma. The approval should come in shortly.  The decision was passed on to the EMA, as the member state did not reach a unanimous decision as one of the countries disagreed to the positive risk-reward assessment issued by the reference state, the UK.

Flutiform when launched will compete with Advair and Symbicort for a market share. The asthma market in Europe is worth about GBP 5.5 billion and has grown at  a CAGR of 6.6% in the last four years.