MedCity News September 23, 2024
Biohaven’s troriluzole, which initially failed a pivotal study in spinocerebellar ataxia, is now being readied for an FDA submission in this rare neurodegenerative disease. The turnabout is based on positive results from a new study that incorporated real-world evidence.
Biohaven is on the cusp of a new drug application filing in a rare neurodegenerative disorder that currently has no approved therapies, a surprising development for a molecule with a long list of clinical trial and regulatory setbacks, including the FDA’s refusal to even review the pill more than a year ago.
But Biohaven did not give up on the drug, and apparently, neither did the FDA. The agency is welcoming more real-world data to generate the evidence for its regulatory...
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