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More relief for Dupixent as FDA pushes back Lilly, Pfizer eczema decisions on safety concerns

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Sanofi and Regeneron can breathe two more sighs of relief for their fast-growing drug Dupixent in atopic dermatitis.

The FDA postponed its rulings on Eli Lilly and Incyte’s Olumiant and Pfizer’s Xeljanz in moderate-to-severe atopic dermatitis by three months, the drugmakers said Wednesday. Both decisions are now expected early in the third quarter.

The announcements came on the heels of a similar delay for AbbVie’s Rinvoq. The delays for the three JAK inhibitors illustrate the FDA’s classwide scrutiny since Xeljanz turned up increased heart-related safety problems in a rheumatoid arthritis safety study earlier this year.

Olumiant, Xeljanz and Rinvoq already bear boxed warnings about serious infections, blood clots and cancers. As the first of the class to enter the market, Xeljanz was required to conduct a long-term post-marketing study to further evaluate those risks.

RELATED: AbbVie’s Rinvoq expansion hits a 2nd snag as FDA delays $2B atopic dermatitis ruling

Pfizer first flagged increased heart risks in that study for a higher Xeljanz dose it tested. But data updated in January found the low dose shared the problem.

As the FDA mulls potential actions on the drug’s existing indications, it’s now taking a closer look at pending applications for the entire JAK class. For both Lilly and AbbVie, the agency requested additional data analyses before extending its decision deadline.

While the postponements were setbacks for JAK developers, they translate into less—or at least delayed—competition for Sanofi and Regeneron’s Dupixent.

Compared with the JAKs, Dupixent has no black box warning. That safety advantage is one reason why industry watchers believed it would be used ahead of the JAKs—even before the Xeljanz safety alert.

RELATED: Lilly’s Olumiant posts trial win in autoimmune hair loss, setting up potential first-in-class FDA nod

Atopic dermatitis is currently Dupixent’s largest indication and a “significant growth driver,” Regeneron commercial chief Marion McCourt said during the company’s fourth-quarter earnings call in February. It helped grow the drug’s sales by 75% year over year to more than $4 billion in 2020.

Eczema patients also appear to stay with Dupixent longer, with about 75% to 80% of them remaining on treatment after six months, which is “higher than industry average and speaks to the drug’s impact on patients’ quality of life,” SVB Leerink analyst Geoffrey Porges summarized in a February note after talking to McCourt during an investor event. 

RELATED: FDA weighs tighter restrictions for Pfizer’s Xeljanz on the heels of safety red flags

Besides the eczema applications, the FDA also rescheduled decisions for Xeljanz in ankylosing spondylitis and previously did the same for Rinvoq in psoriatic arthritis.

Of the three JAKs, first-to-market Xeljanz hauled in the most last year—$2.44 billion—with its indications in rheumatoid arthritis (RA), psoriatic arthritis and ulcerative colitis. That’s a 9% sales increase year-over-year.

Olumiant, officially approved in mid-2018 for RA, has won approval in the EU and Japan for atopic dermatitis. It brought in $639 million in 2020, up 50% over 2019, partly thanks to its emergency use authorization alongside Gilead Sciences’ remdesivir for COVID-19.

Rinvoq only got its U.S. go-ahead in RA in August 2019 and has already registered $281 million in sales for its first full year on the market.

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