EMA Recommends Four Medicines for Approval

November 16, 2018

The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.

EMA announced on Nov. 16, 2018 that its human medicines committee (CHMP) recommended four drugs for approval. The approved drugs include the first oral-only tablet for the treatment of human African trypanosomiasis, commonly known as sleeping sickness, due to Trypanosoma brucei gambiense. The drug, Fexinidazole Winthrop (fexinidazole), has been approved for use outside the European Union under Article 58.

The other recommended drugs include a treatment for non-metastatic castration resistant prostate cancer, Erleada (apalutamide); a treatment for growth hormone deficiency in adults, Macimorelin Aeterna Zentaris (macimorelin); and the generic drug, Silodosin Recordati (silodosin), for the treatment of the signs and symptoms of benign prostatic hyperplasia.

CHMP also recommended extending the indications for Kisqali, Mabthera, Orkambi, and Ravicti. In addition, Blincyto’s (blinatumomab) indication was extended in patients with residual cancer cells after previous treatment. Positive opinions were adopted for the use of Opdivo (nivolumab) and Yervoy (ipilimumab) in combination to treat renal cell carcinoma (kidney cancer).

Source: EMA