Sanofi, Regeneron’s Dupixent scores another indication with first-ever approval for nodular skin disorder

Sanofi chief executive Paul Hudson told investors earlier this year that the Big Pharma was going to emphasize its sales kingpin Dupixent moving forward.

He wasn’t joking — the megablockbuster drug and sales king, recording just shy of $2 billion in sales this past quarter, has now officially secured its fifth indication from the FDA.

Sanofi and Regeneron, who jointly work on Dupixent development and commercialization, announced the new development on Thursday, saying that the FDA gave the all-clear to Dupixent to treat patients with prurigo nodularis, a rare autoimmune disorder characterized by a persistent, severe itch — and also visualized by hard, extremely itchy bumps known as nodules that form on the skin. The FDA noted in its announcement that it is the agency’s first approval for the disease.

Sanofi noted in a statement that the federal regulatory agency greenlit the approval under priority review after the companies submitted data from two pivotal trials, which were direct-to-Phase III.

The first trial, which read out in October last year, showed that 37% of the 78 patients on Dupixent showed a “clinically meaningful reduction in itch from baseline,” comparing that to only 22% of patients on placebo after 12 weeks. With a p-value of p=0.0216, it met the primary endpoint.

The benefits got better after another 12 weeks — 58% of those on Dupixent reached the primary endpoint after 24 weeks, while only 20% of those reached the primary endpoint on placebo. That clocked in at a p-value of p<0.0001.

Naimish Patel

The second trial, with results three months later, essentially verified the 24-week data from the first study. 60% of Dupixent patients saw the “clinically meaningful reduction in itch from baseline” — compared to only 18% of those on placebo, also clocking in a p-value of p<0.0001 for statistical significance.

Sanofi’s R&D immunology chief Naimish Patel tells Endpoints News that Sanofi started looking into the indication after several collaborators and key experts had a hypothesis about type II inflammation, caused by IL-4 and IL-13, and its role in the disease. After looking at real-world evidence and other case series, Patel said that there was support that Dupixent in prurigo nodularis just might work — and so the company decided to go straight to Phase III.

As for what’s next, here’s what Patel said:

We’re going to go to Europe and other markets. We don’t have approval yet, but that’s something in the works already.

The exact timeline for that, though, is still unclear.

This new indication adds to asthma, atopic dermatitis, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyposis — and Sanofi has additional indications in its pipeline for the drug, including chronic pruritus of unknown origin, which Patel said is in the middle of a direct-to-Phase III trial.

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