US FDA approves higher-dose of Biogen's genetic disorder drug
US FDA approves higher-dose of Biogen's genetic disorder drug
ReutersMon, March 30, 2026 at 11:46 AM UTC
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A sign marks a Biogen facility in Cambridge, Massachusetts, U.S. January 26, 2017. REUTERS/Brian Snyder
March 30 (Reuters) - The U.S. Food and Drug Administration has approved a higher-dose version of Biogen's drug for a rare genetic disorder that causes progressive muscle weakness, the company said on Monday, offering patients a potentially more effective option.
The regulator had declined to approve the company's application last year, seeking technical information.
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The new regimen, which will be available in the U.S. in the coming weeks, uses two 50 milligram initial doses given 14 days apart, followed by a 28 mg maintenance dose every four months, compared to the current standard dose of 12 mg, Biogen said.
(Reporting by Mariam Sunny and Kunal Das in Bengaluru; Editing by Shailesh Kuber)
Source: “AOL Breaking”
