The FDA on Thursday greenlit the label expansion of AstraZeneca’s subcutaneous IL-5 receptor blocker Fasenra (benralizumab), which can now be used as an add-on maintenance treatment for severe eosinophilic asthma in children six to 11 years of age.
Tag Archive for: Dupixent
The FDA has granted Priority Review to Sanofi and Regeneron’s supplemental Biologics License Application seeking to expand its blockbuster antibody therapeutic Dupixent (dupilumab) into chronic obstructive pulmonary disease, the companies announced Friday.
Despite strong sales of its blockbuster drug Dupixent, Sanofi reported that its fourth-quarter 2023 operating income dropped 5% due to a weaker U.S. dollar, high expenses and generic competition.
The agency approved the use of Regeneron and Sanofi’s Dupixent to treat an allergic inflammation of the esophagus in children aged one to 11 years old and weighing at least 15 kg.
The company plans to seek U.S. approval for its best-selling anti-inflammatory drug Dupixent to be used in the treatment of “smoker’s lung”, also known as COPD, after a second large trial showed significant benefits.
Today the company beat Wall Street estimates for third-quarter profit, driven by strong demand for its eczema treatment, Dupixent.
The FDA’s schedule is picking up speed, with six target action dates over the next two weeks, including one for a blockbuster cancer treatment and another for a highly anticipated therapy for a rare pediatric disorder.
In 2022, Sanofi’s adherence to its strategy has yielded an expanded pipeline, greater sales and net income, and progress in the use of artificial intelligence.
As the public’s interest in COVID-19 products continues to wane and the autoimmune medicine Humira settles into life without exclusivity, the anti-cancer agent Keytruda is set to rule the drug marketplace for years to come.
The company said it was discussing with major watchdogs across the world whether the trial results are substantial enough to support a regulatory review or whether that will require the results of another ongoing trial.
