On a roll, Dupixent marches into teen eczema, nabs fast FDA review in sinusitis

Sanofi and Regeneron’s next-gen immunology drug Dupixent is on fire. Already on its way to blockbusterland after grabbing a key asthma nod last October, the drug scored two back-to-back regulatory wins at the FDA.

Dupixent snagged a new green light in atopic dermatitis, this time in patients 12 to 17 years of age. That makes it the first biologic treatment for adolescents with eczema and adds a new pool of potential patients to its original approval in adults.

And buoyed by what Regeneron Chief Scientific Officer George Yancopoulos called "overwhelmingly positive" phase 3 results, Dupixent also nabbed expedited review for a new use in adults with severe chronic sinusitis with nasal polyps. That decision is set for June 26.

The new eczema approval was based on a phase 3 trial that showed Dupixent could reduce severity of young patients’ eczema by about 66% versus 24% on a dummy drug. Almost one-quarter of Dupixent patients in the trial gained clear or almost clear skin with treatment, compared with only 2% in the control group.

The number of potential adolescent AD patients is about half the target adult population, Regeneron commercial chief Marion McCourt said during the company’s fourth-quarter earnings call. Sanofi and Regeneron are also looking to bring the drug to even younger AD patients, with phase 2 results in patients aged 6 to 11 due later this year. 

A sinusitis nod would bring Dupixent into an entirely different disease. The med recently slayed two phase 3 trials in sinusitis with nasal polyps, checking all primary and secondary endpoints. After 24 weeks, patients treated with Dupixent on top of steroid nasal spray in the two trials saw either a 51% or 57% reduction in nasal obstruction levels, respectively, compared with 15% and 19% with steroid treatment alone. Polyps shrank by 27% and 33% in the Dupixent groups, but grew in placebo patients, by 4% and 7%, respectively.

Dupixent is aiming to be the first biologic in sinusitis, where patients often see polyps return after surgery or long-term steroid treatment.

The two new uses would add more fuel to the IL-4 and IL-13 blocker's engine, and it's already well on track to cross the blockbuster threshold: It hit €783 million ($883 million) in 2018, its first full year on the market. And after it won approval in asthma, Leerink analyst Geoffrey Porges projected peak sales in that condition alone at $2.5 billion. Total? An even more bullish estimate of $7.5 billion, well above the consensus $5.4 billion.

Besides sinusitis, Sanofi and Regeneron are also gleaning data on Dupixent’s effects in other type 2 inflammatory diseases such as eosinophilic esophagitis.

The pair might as well strengthen their foothold as quickly as possible, given that competitors are well on their way. AbbVie’s blockbuster hopeful upadacitinib, for example, has rolled out positive mid-stage data in AD; at week 32, the oral JAK inhibitor delivered in greater improvements in itch and skin lesions across all three dose regimens.

During Sanofi’s fourth-quarter call, Genzyme head Bill Sibold played down the potential threat, though—despite the fact that an oral treatment would boast a convenience edge over Dupixent’s injectable form.

"We believe that we have the best product profile from both an efficacy and a safety perspective with any of the products that we've seen any information on in the pipeline," he said. Sibold pointed out that dermatologists are very safety conscious, and therefore will keep a closer eye on JAKs, not just in atopic dermatitis but in other indications as well.

Safety is indeed proving a sting for the JAK class, what with the recent fallout in a Xeljanz postmarketing CV study that both the FDA and EMA are investigating. And a upadacitinib phase 3 in arthritis previously saw a hemorrhagic stroke death and a pulmonary embolism case, but both of them in patients the company said had pre-existing CV risk factors.

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