EMA Highlights: EMA gives green light for new drugs

by Gary Finnegan: Ten medicines, including a first-in-class orphan medicine for narcolepsy, were recommended for authorisation in the EU at the latest meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The Committee approved the following:

• Wakix(pitolisant) for the treatment of narcolepsy, a rare, long-term sleep disorder which affects the brain’s ability to regulate the normal sleep-wake cycle.
• Oncaspar(pegaspargase) and Spectrila (asparaginase), both for the treatment of acute lymphoblastic leukaemia. Spectrila has an orphan designation.
• Benepali(etanercept), a biosimilar, for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.
• Briviact(brivaracetam) for the treatment of partial-onset epilepsy seizures.
• Episalvanfor the treatment of partial thickness wounds in adults. The active substance of Episalvan is birch bark extract.
• Pemetrexed Accord(pemetrexed) for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer.
• Lopinavir/ Ritonavir Mylan (lopinavir / ritonavir) for the treatment of human immunodeficiency virus (HIV) infection in adults, adolescents and children above the age of two years.
• Eptifibatide Accord(eptifibatide) for the prevention of early myocardial infarction.
• Pemetrexed Actavis(pemetrexed), one ‘hybrid medicine’ for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer. Hybrid applications rely in part on the results of studies carried out with a reference product and in part on new data.