Batch of EMA/CHMP recommendations for extensions of indications

1 May 2020

The April deliberations of the European Medicines Agency’s Committee for Medicinal Product for Human Use (CHMP) resulted in a batch of label extensions for already marketed drugs, as well as several novel drugs ( see separate story).

Braftovi (encorafenib), from France’s Pierre Fabre, saw its label changed to the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation who have received prior system therapy.

Cablivi (caplacizumab), from Belgium’s Ablynx (Euronext Brussels: ABLX), is now indicated for the treatment of adults and adolescents of 12 year and older weighing at least 40kg experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.

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