Just after announcing the approval of the Tudorza Pressair aclidinium bromide dry powder inhaler for the treatment of COPD in the US, Almirall has announced that the European Commission has granted marketing approval to its aclidinium DPI, which will be marketed as the Eklira or Bretaris Genuair in Europe. The approval applies to all EU member states, Iceland and Norway.
The Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the product in May 2012. A few months earlier, Almirall had licensed most of the European rights to Menarini. Almirall will market the product as Eklira Genuair; Menarini will market it as Bretaris Genuair.
Almirall CEO Eduardo Sanchiz said, “Almirall and its European partner Menarini are pleased with the approval of Eklira/Bretaris Genuair, an important milestone in Almirall’s respiratory franchise, one of our key R&D areas. We are convinced from our large set of scientific data that aclidinium will help patients in Europe to reduce COPD symptoms and improve their quality of life.”
Read the Almirall press release.
