Three new drugs recommended for approval by EMA/CHMP

Three new medicines have been recommended for approval at the February 2015 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The Committee has recommended granting a marketing authorisation for Japanese drugmaker Otsuka Pharmaceuticals’ (TYO: 4768) Jinarc (tolvaptan) for the treatment of patients with autosomal dominant polycystic kidney disease (ADPKD). Jinarc has an orphan designation.

No medicine is specifically authorized in the European Union to treat patients with ADPKD. Current treatment focuses on the treatment of symptoms and complications. There is therefore a clear unmet need for an effective therapy for ADPKD.Tolvaptan, a vasopressin-2-receptor antagonist, is already authorized in the EU for treating hyponatremia (abnormally low sodium levels) although the doses studied in ADPKD are different.