Europe Approves Sanofi/Regeneron's Dupixent for 'Smoker's Lungs' A Month After US FDA Asks For Data
Portfolio Pulse from Vandana Singh
The European Medicines Agency (EMA) has approved Sanofi and Regeneron's Dupixent for use in treating chronic obstructive pulmonary disease (COPD) in adults, marking the first approval of its kind globally. This approval is based on positive results from the phase 3 BOREAS and NOTUS studies. The FDA has requested additional data before making a decision on Dupixent's approval for COPD in the US.
July 03, 2024 | 12:55 pm
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POSITIVE IMPACT
Regeneron's Dupixent has received EMA approval for COPD, the first such approval globally. This could enhance Regeneron's market presence and revenue streams.
The EMA approval of Dupixent for COPD is a major achievement for Regeneron, likely to boost its market presence and revenue. The drug's efficacy as demonstrated in phase 3 studies supports this positive outlook.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100
POSITIVE IMPACT
Sanofi's Dupixent has been approved by the EMA for treating COPD, marking a significant milestone as the first global approval for this indication. This could potentially boost Sanofi's market position and revenue.
The EMA approval of Dupixent for COPD is a significant milestone for Sanofi, potentially increasing its market share and revenue. The positive results from the phase 3 studies further support the drug's efficacy.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100