Batch of drug recommendations from EMA/CHMP September meeting

26 September 2014

Some 15 new medicines have been recommended for approval at the September meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The Committee recommended a marketing authorization for US biotech firm Gilead Sciences (Nasdaq: GILD) Harvoni (sofosbuvir/ledipasvir) for the treatment of chronic hepatitis C in adults. Harvoni belongs to a new generation of antiviral products for chronic HCV infection that have high cure rates and have recently reshaped the treatment landscape for this disease.

Ketoconazole HRA (ketoconazole) from Laboratoire HRA Pharma was recommended by the CHMP as a new treatment for patients with Cushing’s syndrome. Pharmacological options for this condition remain very limited and there is an unmet medical need for additional medicines. Ketoconazole HRA has an orphan designation.

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