Health
European Commission Grants Conditional Approval of EZMEKLY® (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
– EZMEKLY is the first and only therapy to receive marketing authorization in the EU for both adults and children (≥2 years) with NF1-PN, a rare genetic disorder with debilitating symptoms –STAMFORD, Conn., July 18, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced today that the European Commission (EC) granted conditional marketing authorization for EZMEKLY® (mirdametinib) for the treatment of symptomatic, inoperable plex
About this update from Merck Kgaa
[{"type":"image","alt":"SpringWorks Therapeutics, Inc.","displaySize":"","headline":null,"caption":"SpringWorks Therapeutics, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":300,"url":"https://media.zenfs.com/en/globenewswire.com/840dd9f662cf5108f1bbf2ee7b87a0b5"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/00lZNVAlsaQPGWZSquDP.g--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTQyMDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/840dd9f662cf5108f1bbf2ee7b87a0b5","width":300,"height":300}},"lazy":false},{"type":"text","content":"– EZMEKLY is the first and only therapy to receive marketing authorization in the EU for both adults and children (≥2 years) with NF1-PN, a rare genetic disorder with debilitating symptoms –","length":190,"tagName":"p"},{"type":"text","content":"STAMFORD, Conn., July 18, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced today that the European Commission (EC) granted conditional marketing authorization for EZMEKLY® (mirdametinib) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above. EZMEKLY is the first and only therapy approved in the European Union (EU) for both adults and children with NF1-PN.","length":542,"tagName":"p"},{"type":"text","content":"“Patients with NF1-PN often face physical and mental health challenges and impaired quality of life given the limited treatment options available for this lifelong and debilitating disease,” said Ignacio Blanco, MD, PhD, Chairman of the National Reference Center for Adult Patients with Neurofibromatosis at Hospital Universitari Germans Trias i Pujol, Spain. “This approval represents an important advance, especially for adults who previously did not have an approved treatment. In clinical trials, EZMEKLY demonstrated an encouraging efficacy and safety profile in both adults and children, and importantly, is available in a tablet that dissolves easily in water for people who are unable to swallow a pill and could therefore not previously receive therapy.”","length":768,"tagName":"p"},{"type":"text","content":"“This European Commission approval is an important milestone for NF patients and caregivers, as it means more treatment options for patients with plex...