The FDA, European Medicines Agency Indicated That A Single, One-year, 2:1 Randomized, Placebo-controlled Trial Would Be Acceptable As A Registrational Study For Bridgebio Pharma's Infigratinib Approval For Children With Achondroplasia
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The FDA and European Medicines Agency have indicated that a single, one-year, 2:1 randomized, placebo-controlled trial would be acceptable as a registrational study for BridgeBio Pharma's Infigratinib approval for children with Achondroplasia. The trial is expected to start by the end of 2023.
September 06, 2023 | 11:36 am
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POSITIVE IMPACT
BridgeBio Pharma's Infigratinib has received approval from the FDA and EMA for a one-year trial for children with Achondroplasia. This could potentially lead to a new revenue stream for the company if the trial is successful.
The approval of the trial by the FDA and EMA is a positive development for BridgeBio Pharma. If the trial is successful, it could lead to the approval of Infigratinib for children with Achondroplasia, opening up a new market for the company and potentially increasing its revenues.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100