European Commission grants conditional approval of Ezmekly

Merck Serono

18 July 2025 - Ezmekly is the first and only therapy to receive marketing authorisation in the EU for both adults and children (≥2 years) with neurofibromatosis type 1 a rare genetic disorder with debilitating symptoms.

Merck announced today that the European Commission granted conditional marketing authorisation for Ezmekly (mirdametinib) for the treatment of symptomatic, inoperable plexiform neurofibromas in paediatric and adult patients with neurofibromatosis type 1 aged 2 years and above.

Read Merck press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Outcome , Medicine , Europe , Registration