Already approved in six indications, Sanofi and Regeneron can now add chronic obstructive pulmonary disease to the list for their blockbuster injection.
Sanofi and Regeneron’s Dupixent is gearing up to expand its reach even further. Sanofi announced Friday that the FDA has approved the blockbuster biologic as an add-on therapy for chronic obstructive pulmonary disease.
Dupixent is the first biologic medicine approved in the U.S. for chronic obstructive pulmonary disease (COPD), according to the partners, where it has the potential to reach around 300,000 adults with poorly controlled disease and a certain level of blood eosinophils, a type of inflammatory cell that contributes to airway obstruction. COPD causes progressive lung function decline and is the third leading cause of death worldwide.
In a pair of Phase III studies, treatment with Dupixent elicited a 30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations compared to placebo. Statistical improvements were also seen in post-bronchodilator forced expiratory volume levels from baseline at week 12, the secondary endpoint.
Safety was consistent with the existing profile of Dupixent in its other approved indications, with the most common adverse events including viral infections, headache and gastritis. The European Medicines Agency approved the biologic as an add-on maintenance treatment for uncontrolled COPD in July.
“Dupixent once again paves the way and becomes the first and only approved add-on biologic medicine for inadequately controlled COPD, giving patients living with this devastating disease the chance to look forward to the potential of improved breathing and a life with fewer exacerbations,” Sanofi CEO Paul Hudson said in a statement.
This latest approval adds to the long list of indications for which Dupixent is FDA approved, including asthma and eczema.
Dupixent brought in $11.6 billion in 2023 sales, with analysts anticipating another $3.5 billion stemming from the COPD approval, according to Fierce Pharma.
While Sanofi and Regeneron are the first to succeed with a biologic in this indication, competition is likely on the way. Earlier this month, GSK announced topline results from a Phase III trial of its injectable antibody Nucala for COPD. Specific data has not yet been shared beyond a general statement that Nucala led to a “statistically significant and clinically meaningful reduction” in annual rates of moderate or severe exacerbations, compared with placebo. AstraZeneca and Amgen are also planning a Phase III for Tezspire in COPD.
