FDA approves SpringWorks’ Gomekli
The US Food and Drug Administration approved Gomekli (mirdametinib), from SpringWorks Therapeutics (Nasdaq: SWTX), a kinase inhibitor, for adult and pediatric patients two years of age and older with neurofibromatosis type 1 (NF1) – a type of tumor that forms on nerves, who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.
The drug is the first and only FDA-approved medicine for both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN), said SpringWorks, which is currently the subject of advanced takeover talks with Germany’s Merck KGaA (MRK DE).
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