FDA Extends Priority Review Deadline For Regeneron Pharmaceuticals And Sanof's Dupixent For The Treatment Of COPD Patients With Type 2 Inflammation To September 2024
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The FDA has extended the priority review deadline for Regeneron Pharmaceuticals and Sanofi's Dupixent for treating COPD patients with Type 2 inflammation to September 2024. The extension follows the submission of additional efficacy analyses.
May 31, 2024 | 5:55 am
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NEUTRAL IMPACT
The FDA has extended the priority review deadline for Regeneron's Dupixent for COPD treatment to September 2024. The extension follows the submission of additional efficacy analyses, with no concerns raised about the drug's approvability.
The extension of the review deadline indicates a delay in potential market approval, which could be seen as neutral in the short term. However, the lack of concerns about approvability is a positive sign.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80
NEUTRAL IMPACT
The FDA has extended the priority review deadline for Sanofi's Dupixent for COPD treatment to September 2024. The extension follows the submission of additional efficacy analyses, with no concerns raised about the drug's approvability.
The extension of the review deadline indicates a delay in potential market approval, which could be seen as neutral in the short term. However, the lack of concerns about approvability is a positive sign.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80