Regeneron, Sanofi win red-carpet treatment at the FDA for a blockbuster contender

This time, Regeneron and Sanofi didn’t have to buy a priority review voucher to try to speed up their regulatory timeline on a big drug. The FDA gave it to them for free on dupilumab, chopping four months off the review process and marking the PDUFA date on March 29.

R&D Chief George Yancopoulos

R&D Chief George Yancopoulos

The IL-4/IL-13 inhibitor is widely viewed as one of the potential blockbusters most likely to succeed in the market. For Regeneron, it’s a chance to continue to build on a sterling R&D rep. For Sanofi, which has made its collaborations with Regeneron a central feature of its R&D game plan, it’s a shot at some redemption as it looks for new revenue to back its flagging diabetes franchise.

Dupilumab won one of the original breakthrough designations back in 2014 for this drug, which has been through a full slate of three big late-stage studies for atopic dermatitis.

The next few months are shaping up as a victory march for Regeneron and its Big Pharma partner.

“Dupilumab is really a franchise unto itself,” R&D chief George Yancopoulos told analysts recently. The drug is also in pivotal studies for asthma. Positive data in atopic dermatitis has spurred their belief that the drug has “huge” potential. There’s already significant pentup demand from patients who either don’t respond to currently available remedies or can’t tolerate them, says Regeneron’s executive team. There’s also no other competition in the late-stage pipeline to contend with.

Peak sales estimates tend to hover around $2.5 billion a year, making it a contender to become a top new approval for 2017. Some optimistic sell-siders have pushed their peak estimates to $4 billion or $5 billion.

Sanofi and Regeneron likely won’t need to wait until next year for a reason to break out the bubbly, though. Their drug sarilumab is up for an October 30 PDUFA date at the FDA, with a recent European filing at the EMA to follow up on. Peak sales estimates top $1 billion for this drug, which beat megablockbuster Humira in a head-to-head study on rheumatoid arthritis. This will probably be their second drug to hit the market – the first was the PCSK9 drug Praluent, which has had a slow uptake since its introduction.

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