24 June 2016 - Six new medicines, including one cell-based therapy, recommended for approval.

The European Medicines Agency’s CHMP recommended six new medicines, including one advanced therapy medicinal product (ATMP), for approval at its June meeting.

The CHMP recommended granting a conditional marketing authorisation for the ATMP Zalmoxis as an adjunctive, or add-on, treatment for adult patients receiving a haploidentical haematopoietic stem cell transplant (HSCT) for types of blood cancer to aid immune reconstitution and reduce the risk of graft-versus-host disease. Zalmoxis has an orphan designation.

The Committee also recommended granting a marketing authorisation for Cinqaero (reslizumab) as an add-on treatment for adult patients with severe eosinophilic asthma.

The generic medicine Atazanavir Mylan (atazanavir) was recommended by the CHMP for the treatment of human immunodeficiency virus-1 (HIV-1) infections.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002553.jsp&mid=WC0b01ac058004d5c1