Approvals recommended by EMA's CHMP in April

23 April 2022

The European Medicines Agency’s human medicines committee (CHMP) recommended four medicines for approval in the European Union (EU) at its April 2022 meeting.

The CHMP gave a positive opinion for Filsuvez (birch bark extract) from Ireland-headquartered Amryt Pharmaceuticals (Nasdaq: AMYT) for the treatment of epidermolysis bullosa. The benefit of Filsuvez is its ability to promote healing of EB partial thickness wounds. The most common side effects are wound complications, application site reactions, wound infections, pruritus and hypersensitivity reactions.

Lunsumio (mosunetuzumab) from Swiss pharma giant Roche (ROG: SIX) received a positive opinion from the CHMP for conditional marketing authorization for the treatment of relapsed or refractory (when treatment does not work) follicular lymphoma. The benefits of Lunsumio are the high proportion of patients with a complete response and the durability of the treatment response. The most common side effects are cytokine release syndrome, neutropenia, pyrexia, hypophosphatemia and headache.

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