EMA approves 39 drugs in first half of year
- The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) approved 39 medications for human use between January and June 2014.
- Comparatively, EMA approved 44 drugs in the first half of 2013, and 33 in the first half of 2012.
- Eight of the 39 medications were approved for orphan diseases.
The first six months of 2014 represent a period of innovative drugs coming to market. They qualify as innovative based on either having the potential to meet unmet medical needs, treating diseases for which no treatments were previously available or significantly improving upon existing treatments.
Among recent approvals are GSK’s Mekist (trametinib) and Roche’s Gazyvaro (obinutuzumab)for treatment of cancer. Other examples of first-half approvals include Takeda’s Entyvio (vedolizumab) for treatment of inflammation and BMS’s Daklinza (daclatsavir) for treatment of infections. Daklinza received accelerated approval, as did another medication, Sylvant (siltuximab) for treatment of multicentric Castleman’s disease.
- Pharma Times EMA: 39 human-use drug OKs in first-half 2014