Sanofi, Regeneron score positive Dupixent data in sinusitis as they await key FDA asthma verdict

As the FDA gets set to decide whether Sanofi and Regeneron’s atopic dermatitis drug, Dupixent, can make a bid for asthma sales, the companies are churning out data in a variety of other conditions in hopes of boosting the product even more.

The latest? Positive numbers from two phase 3 trials in patients with rhinosinusitis and nasal polyps that, to Regeneron's mind, not only will support applications for broader use of the drug but show Dupixent's ability to block the inflammatory pathways IL-4 and IL-13 can treat a range of conditions. 

“With these data, Dupixent has now been shown to address this inflammation across the complete airway, which manifests in the upper respiratory tract as polyps and congestion, and in the lower airway as asthma,” Regeneron Chief Scientific Officer George Yancopoulos, M.D., Ph.D., said in a statement.

After 24 weeks, patients treated with Dupixent plus a steroid nasal spray saw a 51% improvement in symptoms in one trial and a 57% improvement in the other, compared to 15% and 19% in patients using the spray alone. Dupixent users saw their polyps shrink 27% in one trial and 33% in the other, versus 4% and 7% increase in polyp size in patients not taking the drug, Sanofi and Regeneron announced.

RELATED: Sanofi, Regeneron pad Dupixent’s case in adolescent eczema ahead of key asthma decision

It’s all part of a much larger development plan for Dupixent, which is the subject of more than a half-dozen clinical trials in indications ranging from peanut allergy to eosinophilic esophagitis.

In fact, the sinusitis data come just a few weeks after Sanofi and Regeneron announced positive phase 3 data from a Dupixent trial in adolescents with atopic dermatitis. The drug is now approved to treat adults only.

During the trial, 25% of patients between the ages of 12 and 17 who took the drug every two weeks saw a complete or near clearance of their symptoms, while only 2% of patients taking a placebo achieved the same result. About 40% of young people taking the drug saw a 75% or better improvement in symptoms, versus just 8% for the placebo group.

The partners could use a Dupixent jump-start. The drug got off to a bit of a slow start after its approval last March, turning in disappointing sales as key gatekeepers such as England’s National Institute for Health and Care Excellence rejected the high-priced antibody. Dupixent sales have started to turn around—at €176 million ($204 million) in sales during the second quarter, it came in 12% ahead of analysts’ expectations—but it's still facing significant challenges.

Potential pricing pushback is at the top of that list. The drug was introduced in atopic dermatitis at $37,000 a year, and even though it’s not yet approved for asthma, one key price watchdog is already raising red flags. In September, the Institute for Clinical and Economic Review (ICER) released a draft report on five biotech drugs for treating allergic asthma, including Dupixent. ICER concluded that the drugs cost between $313,000 and $464,000 per additional quality-adjusted life year gained—and Dupixent is on the high end of that scale. Sanofi and Regeneron would need to discount the drug significantly to make covering it worthwhile for payers, ICER concluded.

RELATED: Big Pharma's antibody drugs for asthma show benefits but cost 50% too much: ICER

Still, analysts maintain high hopes for Dupixent. Estimates of peak sales for the product range from $3 billion to $5 billion. The asthma approval alone could add $2.5 billion to the product’s yearly haul, analysts from Sanford Bernstein and Leerink predict.

Meanwhile, Sanofi is counting on Dupixent to help cushion the blow of falling sales in its flagship diabetes unit. Despite strong Dupixent sales during the second quarter, Sanofi’s overall sales of €8.18 billion ($9.5 billion) were flat year over year, beset by a 30% drop in diabetes sales in the U.S.