- Sanofi and Regeneron's Dupixent has secured U.S. approval for the treatment of moderate-to-severe atopic dermatitis in adolescents — a label expansion that could increase the immunology drug's eligible patient population by at least 150,000, according to Sanofi estimates.
- Regulators based their decision on pivotal trial data showing Dupixent-treated patients experienced on average a 66% improvement in their eczema severity after 16 weeks of therapy, which was well above the 24% seen in a placebo group. That study also found the percentage of patients achieving clear or almost clear skin was more than 10 times higher in the Dupixent arm compared to the placebo arm.
- The first stateside approval of Dupixent was for adults with moderate-to-severe atopic dermatitis, a population Sanofi pegged at 300,000. The French pharma said in its most recent earnings call the number of U.S. adolescents with moderate-to-severe atopic dermatitis is roughly half of the adult population.
Dupixent (dupilumab) has proven a key growth driver for both its developers. Regeneron's latest annual filing says that Sanofi recorded $922 million in net product sales from the drug last year, reflecting a nearly 260% increase from 2017.
Such growth is especially valuable to Sanofi. One of the big three diabetes drugmakers, Sanofi has seen its insulin business knocked back by coverage decisions and pricing pressures — particularly with regard to the company's top-seller, Lantus (insulin glargine). Congressional scrutiny of insulin prices suggests the headwinds are far from over.
Sanofi and Regeneron expect Dupixent to hit blockbuster status this year with its indications for asthma and atopic dermatitis. The drug's growth has already continued into the early months of 2018; total prescriptions for Dupixent increased 7% during the week of March 8, according to IMS data cited by investment bank RBC Capital Markets.
With the new label expansion, Sanofi expects another 150,000 to 200,000 U.S. patients will be eligible to use Dupixent. John Reed, head of the French pharma's R&D, said in a statement approximately 50,000 U.S. patients have been treated with the biologic therapy.
That number will likely increase too as Sanofi and Regeneron work to lock down additional label expansions. The FDA just accepted a filing for Dupixent as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps. The companies also expect to submit regulatory filings for younger atopic dermatitis and asthma patients over the next few years.
While it has shown efficacy across several diseases, Dupixent isn't a perfect fit for many patients.
Jefferies, for instance, detailed in a March note a meeting it had with doctors. One doctor noted how 30% to 40% of adult atopic dermatitis patients on Dupixent are non-responders, and how the drug's mode of administration — injection — is a deterrent for many patients regardless of their response.
A Sanofi spokesperson noted in an email to BioPharma Dive that the Phase 3 CHRONOS trial evaluated Dupixent 300 mg plus topical corticosteroids, a regimen that "potentially aligns more closely with real world data," and found 79% of patients achieved a clinically meaningful response after a year of therapy compared to placebo.