FDA panel backs accelerated approval for Biogen's ALS drug. MedTwitter FDA ALS
- A panel of advisers to the U.S. drug regulator voted that data on Biogen Inc's experimental treatment for ALS, also known as Lou Gehrig's disease, shows that the drug could work, potentially paving the way for an accelerated approval.
The U.S. Food and Drug Administration panel's vote was as expected and supportive of the drug's accelerated approval, said SVB Securities analyst Marc Goodman.In a second vote, the panel said there was not enough convincing evidence to show the effectiveness of tofersen for the disease, reducing the chances of a full approval for now.
If tofersen is approved under the agency's accelerated approval pathway, a confirmatory trial will need to show the drug provides a clinical benefit for it to remain in the market.
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