The FDA plans to review Sanofi‘s (NYSE:SNY) Dupixent monoclonal antibody as an add-on maintenance treatment in adults with moderate-to-severe asthma, according to the pharmaceutical company.
The U.S. regulatory agency is slated to decide whether it will approve this new indication for Dupixent by Oct. 20.
Sanofi’s drug, a subcutaneous injection delivered using a pre-filled syringe, is approved to treat moderate-to-severe atopic dermatitis in the U.S., the European Union, Canada and Japan.
Sanofi said it expects to present data from three pivotal trials evaluating Dupixent as an asthma therapy later this year.
Dupixent, or dupilumab, is a human monoclonal antibody that is designed to inhibit the signaling of interleukin-4 and interleukin-13. These signaling proteins, or cytokines, are thought to contribute to inflammation in asthma patients, according to Sanofi.
“People who live with moderate-to-severe asthma often experience decreased lung function and have severe attacks (exacerbations) that may lead to emergency room visits and hospitalizations. Despite currently available treatments, there remains an unmet need in patients who suffer from decreased lung function, severe exacerbations, long-term oral corticosteroid use and poor quality of life,” the company said in prepared remarks.
