PARIS (Reuters) – Sanofi plans to seek U.S. marketing authorization for its best-selling anti-inflammatory drug, Dupixent, for the treatment of “smoker’s lung”, also known as COPD, after A second large trial showed significant improvements in patients.
A second phase 3 trial for COPD (chronic obstructive pulmonary disease) showed that the treatment reduced exacerbations of the disease by 34%, indicates in a press release the pharmaceutical laboratory, which collaborates with Regeneron on Dupixent.
Therefore, Sanofi intends to file its application with the Food and Drug Administration (FDA) by the end of the year. The European Union’s drug regulator is already considering a similar application based on the first phase 3 trial.
“These data confirm what we thought: Dupixent does indeed have the potential to transform the treatment of moderate to severe COPD,” commented Dr. Naimish Patel, global head of development, immunology and inflammation for the group.
On the Paris Stock Exchange, Sanofi shares rose 1.09% to 87.32 euros at 08:57 GMT, leading the stable CAC 40 at the same time.
For Jefferies analysts, this new development should allow the stock to recover after its sharp fall at the end of October linked to the company’s abandonment of its operating margin objective for 2025.
Jefferies is also expecting more information during the research and development day organized by Sanofi on December 7.
(Reporting Ludwig Burger, written by Kate Entringer, edited by Blandine Hénault)
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