SpringWorks' Neurofibromatosis Therapy Application Receives FDA Priority Review

MT Newswires Live08-28

SpringWorks Therapeutics (SWTX) said on Wednesday that the U.S. Food and Drug Administration had accepted a new drug application for its experimental therapy, mirdametinib, to treat adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas.

The company said the application was granted Priority Review and that a decision was expected by Feb. 28, 2025.

In addition, the FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.

SpringWorks also said that the European Medicines Agency had validated the marketing authorization application for mirdametinib.

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