Indication extensions recommended for nine drugs by CHMP

At its January 28-31 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), as well as giving opinions on six novel medicines, it recommended the extension of indications for nine further drugs, as follows:

Forxiga and its duplicate Edistride (dapagliflozin), from AstraZeneca (LSE: AZN), as an adjunct treatment to insulin in the form of a tablet for certain patients with type 1 diabetes mellitus.

Hemlibra (emicizumab) from Roche (ROG: SIX), for routine prophylaxis of bleeding episodes in adults and children with severe hemophilia A (congenital factor VIII deficiency, FVIII <1%) without factor VIII inhibitors. The CHMP has also recommended that Hemlibra can be used at multiple dosing options (once weekly, every two weeks, or every four weeks) for all indicated people with hemophilia A, including those with factor VIII inhibitors.