Regeneron Pharmaceuticals And Sanofi Announce That Dupixent® sBLA Has Been Accepted For FDA Priority Review For Treatment of COPD With Type 2 Inflammation
Portfolio Pulse from Benzinga Newsdesk
Regeneron Pharmaceuticals and Sanofi have announced that their joint product, Dupixent, has been granted FDA Priority Review for the treatment of COPD with Type 2 inflammation. This comes after positive results from two Phase 3 trials. If approved, Dupixent would become the only biologic therapy for COPD, marking the first new treatment approach for the disease in over a decade. Regulatory submissions for Dupixent are also under review in China and Europe. Currently, Dupixent is the leading biologic treatment in the U.S. for all five of its FDA-approved indications.
February 23, 2024 | 6:40 am
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POSITIVE IMPACT
Regeneron Pharmaceuticals' Dupixent, developed in partnership with Sanofi, has been granted FDA Priority Review for COPD treatment, potentially becoming the first biologic therapy for the disease in over a decade.
The FDA Priority Review of Dupixent for COPD treatment, a product of Regeneron Pharmaceuticals, signifies a significant advancement in the treatment of the disease. Given the positive results from Phase 3 trials and the potential to become the only biologic therapy for COPD, this news is likely to have a positive impact on Regeneron's stock in the short term. The importance is high due to the potential market expansion and the positive implications for the company's product portfolio.
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 90
POSITIVE IMPACT
Sanofi, in partnership with Regeneron Pharmaceuticals, has seen its joint product Dupixent receive FDA Priority Review for the treatment of COPD, potentially marking a significant milestone as the first biologic therapy for the disease.
Sanofi's collaboration with Regeneron Pharmaceuticals on Dupixent, now under FDA Priority Review for COPD treatment, represents a potential breakthrough in the disease's management. The positive Phase 3 trial results and the possibility of Dupixent becoming the first biologic therapy for COPD in over a decade suggest a positive short-term impact on Sanofi's stock. The news is of high importance due to the potential for significant market impact and enhancement of Sanofi's biologic treatment portfolio.
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 90