- Regeneron and Sanofi, who teamed up to develop the cholesterol drug Praluent, released new data on their experimental drug for severe eczema, showing treatment with Dupixent (dupilumab) led to clearing or near-clearing of skin lesions in nearly 40% of adult patients
- Additionally, 52% and 48% of patients on a weekly dosing regimen of Dupixent in each of the two Phase 3 trials saw a 75% of greater reduction in their Eczema Area and Severity Index (EASI-75) score, meeting the key secondary endpoint in the U.S.
- The Sanofi/Regeneron team recently won priority review from the Food and Drug Administration, which set a target decision date on approval of March 29, 2017. Filings are planned for Europe and Japan in late 2016.
Regeneron Pharmaceuticals and Sanofi have been touting the promise of Dupixent (dupilumab). Initial data was published back in April 2016, but the additional data from the two Phase 3 studies testing the drug have further rounded out the positive findings.
"The Phase 3 SOLO 1 and SOLO 2 clinical trials are the first large pivotal studies where a systemic investigational therapy has demonstrated a significant reduction in the signs and symptoms of atopic dermatitis, and showed improvement in studied quality of life measures," said Eric Simpson, a M.D. at Oregon Health & Science University and lead author of the NEJM paper.
Around 1.6 million adults in the U.S. are affected by moderate-to-severe atopic dermatitis, according to The New York Times.
If Dupixent can make a difference to moderate to severe disease, with less of the troubled safety profile seen with corticosteroids and immunosuppressants, it could be a hit on the market — Jefferies predicts blockbuster status, with peak sales of up to $3 billion.
Dupixent's initial focus will be on patients who have failed topical treatment, oral and systemic steroids, or immunosuppressant therapy. A Phase 3 trial in asthma, the pivotal QUEST study, has enrolled but data will be more than a year away.
Sanofi and Regeneron have struggled to grow sales of Praluent (alirocumab), their expensive PCSK9 cholesterol drug, as payers have fought against full coverage. Continued development success of Dupixent could take some of that sting away.