With the FDA’s JAK hesitations wearing on, atopic dermatitis hopefuls from AbbVie and Eli Lilly will have to keep waiting for a chance to see the market.
The companies separately said on Friday that the FDA again delayed decisions over their applications for Rinvoq and Olumiant in moderate to severe atopic dermatitis. Neither provided an updated timeline for the agency’s decision.
The FDA’s deferral is unsurprising given that the agency has already halted verdicts across drugs in the JAK class of medicines for months, Barclays analysts said in a Friday note to clients.
Federal regulators are working through safety concerns shrouding Pfizer’s JAK inhibitor Xeljanz after a post-marketing study earlier this year turned up risks for dangerous heart side effects and cancer. However, “there has been no tangible evidence of progress” concerning the FDA’s review, Barclays said.
Olumiant, Xeljanz and Rinvoq already bear boxed warnings about serious infections, blood clots and cancers. As Xeljanz was the first of the class to enter the market, the FDA required Pfizer to conduct a long-term post-marketing study on its product to further evaluate those risks.
AbbVie and Lilly on Friday reiterated that they remain confident in their candidates. Friday’s FDA delay marks the second holdup for the pair of eczema medicines following an initial setback in April.
At the time, the agency also pushed back a third treatment from Pfizer, abrocitinib, as well as Leo Pharma’s tralokinumab a few weeks later. Those drugmakers haven’t issued an update over their medicines, although Wall Street likely foresees a similar fate. All of the delays are a boon to Sanofi and Regeneron's Dupixent, which is generating blockbuster sales and growing its lead in eczema each day.
AbbVie’s Rinvoq is carrying big expectations and has already run into several FDA delays, including in psoriatic arthritis and ankylosing spondylitis. But the clock is ticking for the Chicago-based pharma given the massive patent cliff it’s facing in 2023 for its top-selling arthritis drug Humira. The company is counting on the JAK inhibitor, alongside Skryizi, to generate $15 billion in sales by 2025.
Both AbbVie and Lilly, along with Pfizer and Leo, are looking to eventually square off with Sanofi and Regeneron’s rapidly growing Dupixent in what could eventually become a crowded eczema space.
Dupixent, the only drug to pass the FDA’s finish line in eczema so far, has been a “significant growth driver,” Regeneron commercial chief Marion McCourt said during the company’s earnings call in February. The drug posted a 75% sales increase to more than $4 billion.