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SpringWorks Hopes Pediatric Plus Adult Data Make Mirdametinib Go-To For NF1-PN

 
• By Alaric DeArment

The company plans to file for FDA approval in the first half of 2024 as it eyes a market of about 40,000 adult and pediatric patients in the US.

SpringWorks announced data from its Phase IIb trial of mirdametinib in the rare disease NF1. • Source: Shutterstock

SpringWorks Therapeutics Inc. has a potentially significant market opportunity with positive data in hand from its Phase IIb ReNeu trial of mirdametinib in pediatric and adult patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), compared with existing options that are only available for pediatric patients.

SpringWorks announced the results of the trial on 16 November, stating that it plans to seek US Food and Drug Administration for the drug, a MEK inhibitor, during the first half of 2024, along

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Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

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• By Kevin Grogan

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• By Andrew McConaghie

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