Drug Development, Regulatory

Going gangbusters in atopic dermatitis, the FDA hands Sanofi and Regeneron a fresh coup for their mega-blockbuster star Dupixent

Just days after Sanofi CEO Olivier Brandicourt proudly showed off the pharma giant’s return to growth with the stellar performance of Dupixent leading the way, the French company and its longtime allies at Regeneron laid claim to a fresh coup for the franchise, gaining a priority review designation at the FDA for expanding the drug’s reach to adolescents with moderate to severe atopic dermatitis.

The IL-4/IL-13 inhibitor is now up for a speedy decision by March 11, which will help keep the sales team forging steadily ahead as researchers continue to push new indications and a wider patient population.

Olivier Brandicourt

Sanofi reported Q3 sales of $262 million for Dupixent, well ahead of forecasts as the drug continues to gain traction among adults with AD. The lion’s share of that money is coming from the US. That’s helped inspire a bullish assessment from Leerink’s Geoffrey Porges, who is estimating 2019 sales of $1.75 billion — with peak sales stretching past the $7 billion mark.

Consensus for the peak is over the $5 billion mark.

A full $2.5 billion of Porges’ $7.5 billion tally is being laid at the door of the asthma market, which the analyst concluded in late October was likely after Sanofi and Regeneron won what he felt was the ideal label for that indication — putting it in the lead to a major market.

The aggressive posture with this drug underscores the absolute and growing importance of pushing groundbreaking new drugs into the marketplace. These days, it’s not how many drug approvals you get, but whether your new drugs can earn billions. And the big blockbusters are still few and far apart.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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