- The Food and Drug Administration on Tuesday gave the thumbs up to a highly anticipated skin disease drug from Sanofi and Regeneron, ahead of tomorrow's prescription user fee action date.
- Dupixent (dupilumab) gained approval as a treatment for adult patients with moderate-to-severe atopic dermatitis, better known as eczema. Industry followers expect the drug will be a major boon to both Sanofi and Regeneron's bottom lines. Analysts' consensus estimates anticipate $3 billion in peak annual sales.
- Sanofi and Regeneron's treatment works by inhibiting IL-4 and IL-13, which are part of a class of small proteins called cytokines that help control the body's immune response. Research suggests eczema is associated with an overactive immune system, and therefore reducing cytokine activity is thought to mitigate the disease.
Sanofi and Regeneron expect to launch Dupixent later this week with an annual wholesale acquisition cost (WAC) of $37,000 in the U.S., though the companies expect patients will pay less than that due to rebates, discounts and other cost-cutting measures, according to a March 28 statement from Regeneron.
"Dupixent is the result of years of tireless research by our scientists into the underlying causes of allergic and atopic diseases," Regeneron CEO George Yancopoulos said in the statement. "In atopic dermatitis, Dupixent was shown to help clear the skin and manage the intense itch caused by the disease."
The FDA's greenlight follows two Phase 3 studies that showed Dupixent outperformed placebo in reducing the disease based on the Eczema Area and Severity Index (EASI) score.
After 16 weeks, 52% and 48% of the patients in the respective studies who received weekly doses of the drug demonstrated 75% fewer lesions. Those figures contrast the 15% and 12% seen in the placebo arm across the two trials. What's more, 51% and 44% of patients taking Dupixent bi-weekly saw their EASI scores decrease by at least 75%.
Patients whose eczema is not managed fully by topical prescription medications can now use Dupixent as a self-administered, bi-weekly injection following an initial dose. Notably, the drug can be taken without topical corticosteroids, a class of treatments that have raised safety concerns in the past.
According to a 2015 report from business research firm GlobalData, the global eczema market is slated to grow to $7.3 billion by 2024, with a compound annual growth rate of 7.5%. And the National Eczema Association estimates about 17.8 million people in the U.S. have moderate to severe eczema or atopic dermatitis.
“Eczema can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients, including those patients whose disease is not controlled by topical therapies," the FDA said in a March 28 statement.
Dupixent's approval comes at an opportune time for both companies.
On Sanofi's end, U.S. diabetes revenues have been forced down by increased pricing pressure and competition in the space. The company's top selling product, Lantus (insulin glargine injection), lost exclusivity and saw sales plummet more than 10% in 2016, according to the Sanofi's most recent annual filing with the Securities and Exchange Commission.
And while a strong performance from the company's Genzyme unit helped buoy sales, lower revenues across traditionally more profitable segments such as cardiovascular products has underscored the need for pipeline and portfolio innovation. In response, Sanofi has pushed to flesh out its immunology offerings.
On Regeneron's end, the company has forecasted slower than desired sales growth for its blockbuster eye drug Eylea (aflibercept). Disappointing revenues from cholesterol drug Praluent (alirocumab), which Regeneron also developed through a partnership with Sanofi, aren't helping the drugmaker's financial position either.
Given the need for Dupixent to do well, both companies have been preparing to make the drug's rollout a success. They have lined up a sales force targeting the 7,000 U.S. dermatologists with experience in biologics, and last week lobbed a preventative patent strike against long-time rival Amgen.
Sanofi and Regeneron filed a lawsuit claiming Dupixent doesn't infringe on a patent the Thousand Oaks, Calif.-based pharmaceutical company holds pertaining to an asthma candidate that was shelved several years back.