The FDA has approved a first-of-a-kind drug for a rare form of ALS, though it will require additional research to confirm the drug's benefit. Patients hope the decision could lay the groundwork for more expedited approvals to fight the disease.
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This image provided by Biogen in April 2023 shows the company's drug Qalsody. On Tuesday, April 25, 2023, the FDA approved the 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. This image provided by Biogen in April 2023 shows the company's drug Qalsody.
WASHINGTON — 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. The FDA approved Biogen’s injectable drug for patients with a rare genetic mutation that’s estimated to affect less than 500 people in the U.S. It’s the first drug for an inherited form of ALS, or amyotrophic lateral sclerosis, a deadly disease that destroys nerve cells needed for basic functions like walking, talking and swallowing.
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
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Drug for rare form of ALS disease OK’d by FDABiogen’s injectable drug is for patients with a rare genetic mutation that’s estimated to affect less than 500 people in the U.S.
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Drug for rare form of Lou Gehrig’s disease OK'd by FDAU.S. health regulators have approved a first-of-a-kind drug for a rare form of Lou Gehrig’s disease
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FDA Approves Drug for Rare Form of Lou Gehrig's DiseaseApproval came via FDA’s accelerated pathway, which allows drugs to launch based on promising early results, before they’re confirmed to benefit patients.
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