The European Medicines Agency (EMA) has accepted Regeneron and Sanofi’s dupilumab for review. Dupilumab’s filing is chock-full of clinical trial data showing it improves multiple outcomes in patients with moderate-to-severe atopic dermatitis, leading to the IL-4/IL-13 inhibitor being widely seen as the next blockbuster to roll off the lot at Regeneron.
The EMA’s acceptance of the marketing authorization application for review means Regeneron and Sanofi are now advancing toward approvals on both sides of the Atlantic. The process is slightly further along in the U.S., where dupilumab has a PDUFA date of March 29 as a result of the FDA accepting it for priority review. The EMA will still be reviewing the dupilumab filing when the FDA makes its ruling.
Dupilumab, which is due to be sold as Dupixent, has acquired blockbuster-in-waiting status among analysts on the strength of a string of stellar data drops in a hard-to-treat population. Phase 3 data link the monoclonal antibody to a reduction in itching, clearing of skin lesions, decline on eczema clinical scales and the easing of anxiety and depression. The data mean dupilumab is tipped to make a difference to the lives of an underserved population—and rack up blockbuster sales doing so.
If everything goes to plan, commercial teams will avoid the slow start that blighted Regeneron and Sanofi’s introduction of Praluent. And the R&D units will push ahead with turning dupilumab into the one-drug franchise envisaged by Regeneron R&D chief George Yancopoulos.
Sanofi and Regeneron are running phase 2 and 3 trials of dupilumab in asthma, nasal polyps and eosinophilic esophagitis. Success in these studies would ratchet up expectations that dupilumab can surpass consensus sales forecasts and hit the $5 billion a year highs foreseen by some analysts.
A clutch of drugmakers are hoping to disrupt these rosy forecasts by coming from behind to steal a slice of the moderate-to-severe atopic dermatitis market, although they face deep-pocketed rivals that have a sizable head start and stellar data in the bank.
The daunting task hasn’t deterred companies. Denmark’s LEO Pharma joined the race in July when it paid $115 million upfront for the rights to AstraZeneca’s candidate tralokinumab in dermatology indications. And Galderma added its name to the list of hopefuls later that month when it picked up a mid-phase program from Roche’s Chugai Pharmaceutical.