Sanofi’s Dupixent wins U.S. approval for bigger use -Breaking
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© Reuters. FILE PHOTO: Sanofi’s logo was displayed at its headquarters in Paris during the annual results conference, Paris France, 02/04/2022. REUTERS/Benoit Tessier(Reuters) -Sanofi has been granted expanded U.S. approval of its Dupixent treatment for allergic inflammation of the esophageal tract, according to the Food and Drug Administration.
According to the American Society of Eosinophilic Esophagitis, there are over 160,000 people in America with EoE. Sanofi (NASDAQ:).
Sanofi has submitted its regulatory file for EoE to the European Medicines Agency. The company stated that it is being reviewed and added that additional submissions will be made by regulatory authorities in the future.
Chronic conditions often require repeated treatment such as diet changes and corticosterioids to relieve symptoms. Dupixent, however, is the first treatment to target the root cause.
Dupixent is an anti-inflammatory drug that was jointly developed by Regeneron (NASDAQ) and has been approved for use in severe asthma, atopic dermatology, and severe eczema.
The shares of Regeneron closed up 1% Friday as the company’s stock reversed its course.
Sanofi stated in March that it expects peak annual sales exceeding 13 billion euros ($13.77 Billion) for its drug. This is an increase from the previous goal of 10 billion.
This excludes the possibility of chronic obstructive lung disease (COPD), also known as smoker’s lung. Trial results will be available next year.
Dupixent, which had 2021 sales in excess of 5.25 Billion Euros, was 13.9% of the group’s revenue. It is Sanofi’s best-selling product.
Sanofi reported an increase of 16.2% in its adjusted earnings during the quarter, mainly due to strong sales and rebounding demand for prescription drugs.
Dupixent revenue increased by over 45%, to 1.61 billion euro in quarter. Analyst consensus was higher, due to prescriptions related to dermatitis, asthma, and other nasal infections.
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