The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for approval of Almirall’s Eklira Genuair aclidinium DPI for the treatment of COPD. The Genuair inhaler is a proprietary multidose, cartridge-based dry powder inhaler.
Almirall Chief Scientific Officer Bertil Lindmark commented,”The Committee’s positive opinion today marks a significant step forward in bringing to prescribers and patients this novel treatment from Almirall’s discovery, and validates the strong data supporting aclidinium’s efficacy and safety in treating COPD. This positive opinion also supports Almirall’s commitment to respiratory research which is set to deliver a robust pipeline of further drugs currently in development.”
Almirall licensed rights to aclidinium in most of Europe to Menarini in March 2012. Menarini will market the product as Bretaris Genuair. Almirall retains the right to market the product (as Eklira Genuair) in the UK, the Netherlands, and the Nordic countries.
In the US, the Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended approval of the NDA in February 2012, but the FDA has extended its review period until July 2012.
Almirall says that it is also ready to move abediterol, a LABA/ICS combination for the treatment of asthma and COPD, into Phase 2b development everywhere except for in the US.
Read the Almirall press release.
