Late-stage trial data suggests Sanofi and Regeneron’s Dupixent is on its way to becoming the first biologic treatment for COPD. A phase 3 study comparing the results of Dupixent against a placebo found that in 939 COPD patients with type 2 inflammation, the drug was able to reduce moderate or severe exacerbations significantly. Over the course of 52 weeks, a 30% reduction was observed among participants who were either active or former smokers on maximal standard-of-care inhaled therapy.
The study was able to meet both its primary and secondary endpoints and succeeded because, unlike biologics in the past, it targets the IL-4 and IL-13 pathways. Previous therapies such as AstraZeneca’s Fasenra and GSK’s Nucala may have failed because they only targeted IL-5 proteins. According to Dietmar Berger, Sanofi’s chief medical officer, the failure of investigational treatments in the past had left COPD patients vulnerable. Sanofi’s audacious decision to directly go into the phase 3 program has been instrumental in accelerating developmental timelines.
“Dupixent has an effect on blocking the action of those cytokines,” Paul Rowe, Sanofi’s head of global medical immunology explained. “By blocking those cytokines, we’re able to potentially also impact the inflammation and hence, have a chance at impacting those irreversible causes.” After Sanofi and Regeneron released a joint statement sharing how the treatment showed improvements in lung function, quality of life, and respiratory symptoms in former and current smokers, Freh group Sanofi’s stock went up by over 5%.
Regeneron similarly saw an 8.6% jump in its U.S. premarket trade. Chronic obstructive pulmonary disease (COPD) is a disease characterized by a progressive decline in lung function and has also become the world’s third leading cause of death. With the results demonstrated in this study, Dupixent is on its way to becoming the first antibody to limit COPD events. Last year, Dupixent rang up sales of around $8.7 billion.
After taking into account the recent blowout data, Richard Vosser, a JP Moran analyst, has estimated that according to market consensus for 2027, Dupixent sales will go over $15 billion. It is likely that the estimated figure would go over by 1-2 billion. Evaluate Pharma has similarly made projections that sales will reach $18 billion by 2028. However, to ensure that both firms do not become increasingly dependent on the drug, CEO Paul Hudson has announced the acquisition of Prevention Bio.
He explained that the group will be working on building on the U.S.-approved type 1 diabetes therapy. Prevention Bio has been acquired for an estimated $3 billion. Two new products would be debuted in the market this year, and these include haemophilia A treatment Altuviiio, and Beyfortus, a preventative treatment against RSV in infants. The latter will be developed in collaboration with AstraZeneca.
When Dupixent was originally approved as a treatment in 2017, it was approved for the treatment of eczema and later for asthma. Soon after, the FDA endorsed it for the treatment of three other inflammatory diseases, and now the European Commission has also approved it to treat severe atopic dermatitis in young children.