- The top-selling product for French pharmaceutical giant Sanofi now has two more competitors in the U.S. market, as the Food and Drug Administration on Friday approved medicines from AbbVie and Pfizer for the treatment of eczema.
- AbbVie's Rinvoq and Pfizer's Cibinqo each work by suppressing Janus kinases, or JAKs, a group of proteins that regulate the immune system and inflammation. Rinvoq had previously been cleared by the FDA to treat two kinds of arthritis, whereas Friday's approval was the first for Cibinqo in the U.S.
- Both AbbVie's and Pfizer's drugs are taken orally, a convenience which could eventually help them compete against injectable eczema treatments like Sanofi and Regeneron's Dupixent. Over the first nine months of 2021, Sanofi recorded 3.7 billion euros — or roughly $4.4 billion — in net sales of Dupixent.
Rinvoq and Cibinqo are crucial assets to their respective developers. For AbbVie, the looming threat of generic competition to Humira — a drug that accounts for nearly 40% of the company's net revenue — has made getting new, lucrative products on the market all the more important. On that front, Rinvoq and another anti-inflammatory drug called Skyrizi are essential, with AbbVie forecasting more than $15 billion in combined sales by 2025.
Pfizer, meanwhile, has built an immunology business around a different JAK-blocking drug known as Xeljanz, which was first approved in 2012 for certain rheumatoid arthritis patients. Though still a blockbuster, Xeljanz sales have started to decline thanks to newfound safety concerns as well as market crowding. Cibinqo, which is known too by its scientific name abrocitinib, is meant to build the business out further.
Friday's approvals could therefore provide a valuable lift to both companies. AbbVie, for example, estimates that Rinvoq will generate $1.7 billion as an eczema treatment in 2025.
The FDA cleared Rinvoq and Cibinqo for patients with moderate to severe eczema whose disease is not adequately controlled with other drugs, including biologic treatments like Dupixent. In a recent presentation, Pfizer said that eczema — which is also called atopic dermatitis — affects up to 10% of adults around the world and up to 20% of children, with a third of those patients experiencing moderate to severe disease.
In the U.S., there are around 6.5 million adults and 3.2 million children with moderate to severe eczema, according to Pfizer.
The FDA also stipulated in its approvals that AbbVie's and Pfizer's treatments could be used in situations where other pills or injections are not recommended. The approval for Cibinqo covers adult patients, while the one for Rinvoq includes adults and children aged 12 years and older.
"Despite available therapies, many people with moderate to severe atopic dermatitis are caught in an endless cycle of itching and scratching," said Emma Guttman-Yassky, Waldman Professor and System Chair of Dermatology at the Icahn School of Medicine at Mount Sinai, said in a statement from AbbVie.
Rinvoq, with its two dose strengths and ability to be taken orally, "is a welcome addition to the toolbox of clinicians," Guttman-Yassky added.
Sanofi may be less excited for these two latest additions, given that Dupixent sales have helped buoy the company over the past few years. Cibinqo could be of particular concern in the future, as Pfizer said last summer that a recent head-to-head study showed its drug cleared skin and reduced itching in more eczema patients than did Dupixent.