Biogen’s injectable drug is for patients with a rare genetic mutation that’s estimated to affect less than 500 people in the U.S.
Food and Drug Administration regulators on Tuesday approved a first-of-a-kind drug for a rare form of Lou Gehrig’s disease, though they are requiring further research to confirm it truly helps patients.
Approval came via FDA’s accelerated pathway, which allows drugs to launch based on promising early results, before they’re confirmed to benefit patients. That shortcut has come under increasing scrutiny from government watchdogs and congressional investigators. ALS patients hope the decision could lay the groundwork for more expedited approvals to fight the disease, which affects 16,000 to 32,000 people in the U.S. The FDA has long used accelerated approval to speed the availability of drugs for cancer and other deadly conditions.
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