EMA/CHMP: six recommendations on extensions of indications

27 March 2021

Following its March meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced recommendations for the extension of indications on six already approved drugs.

These were as follows:

GlaxoSmithKline’s (LSE: GSK) Benlysta (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN).

Kaftrio (ivacaftor/tezacaftor/elexacaftor), from Vertex Pharmaceuticals (Nasdaq: VRTX), to extend the use in all patients with at least one F508del mutation.

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