EMA/CHMP November meeting highlights

The European Medicines Agency’s Committee for Products for Human Use (CHMP) recommended four medicines for approval, including one for use in countries outside the European Union, at its November 2018 meeting, as well as two re-examinations and four indication extensions.

The CHMP adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), from Sanofi (Euronext: SAN), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis, commonly known as sleeping sickness, due to Trypanosoma brucei gambiense . This is the tenth medicine recommended by the EMA under Article 58, a mechanism that allows the CHMP to assess and give opinions on medicines for use outside the European Union.

Erleada (apalutamide), from Johnson & Johnson (NYSEL JNJ) subsidiary Janssen-Cilag, received a positive opinion for the treatment of non-metastatic castration resistant prostate cancer.The benefits with Erleada are its ability to delay metastatic disease, the EMA stated. The most common side effects are fatigue, skin rash, weight decrease, arthralgia and falls.