The U.S. Food and Drug Administration on Monday approved expanded use of Regener...
FILE PHOTO: The logo of Sanofi is pictured during the Viva Tech start-up and technology summit in Paris, France, May 25, 2018. REUTERS/Charles Platiau
(Reuters) - The U.S. Food and Drug Administration on Monday approved expanded use of Regeneron Pharmaceuticals Inc and Sanofi SA’s eczema drug Dupixent to include patients aged 12 and older, a boost for both the companies in the world’s largest market for drugs.
Shares of Regeneron rose 1.8 percent to $410.17 on Monday.
The FDA first approved the drug in 2017 and it has since been launched as a treatment for adults with moderate-to-severe atopic dermatitis, or eczema, as well as a drug for some asthma patients.
The companies estimates that there are about 300,000-400,000 adults in the United States who are most in need of treatment, and that the number of adolescent patients is about half of this population.
Dupixent represents an important growth driver for both the companies.
In recent years, Regeneron’s investors have been focusing on newer drugs such as Dupixent, as the company’s flagship drug, Eylea, faces increased competition.
Meanwhile, Sanofi has been placing hopes on continued upswing for the drug as it faces weakness in its diabetes business due to generic rivals.
The drug, which brought in $922 million in revenue for Sanofi in 2018, gained a U.S. FDA nod last year for use as a maintenance therapy in patients with two forms of asthma.
Piper Jaffray analysts, before the approval, said they expected U.S. sales of $661 million in 2021 from Dupixent’s use in treating adolescents alone.
Reporting by Manas Mishra and Tamara Mathias in Bengaluru; Editing by Maju Samuel