FDA Extends Review Deadline For Regeneron/Sanofi's Dupixent For 'Smoker's Lungs' Disease
Portfolio Pulse from Vandana Singh
The FDA has extended the review deadline for Regeneron and Sanofi's Dupixent for treating COPD to September 27, 2024. The extension follows the submission of additional efficacy analyses. The European Medicines Agency has also recommended approval of Dupixent for COPD in the EU.
May 31, 2024 | 1:23 pm
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NEUTRAL IMPACT
The FDA has extended the review deadline for Regeneron's Dupixent for COPD to September 27, 2024, following additional efficacy analyses. The EMA has recommended approval in the EU.
The extension of the FDA review deadline introduces a delay in potential market approval in the US, which could be seen as a neutral to slightly negative short-term impact. However, the positive opinion from the EMA is a positive development.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100
NEUTRAL IMPACT
The FDA has extended the review deadline for Sanofi's Dupixent for COPD to September 27, 2024, following additional efficacy analyses. The EMA has recommended approval in the EU.
The extension of the FDA review deadline introduces a delay in potential market approval in the US, which could be seen as a neutral to slightly negative short-term impact. However, the positive opinion from the EMA is a positive development.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100