Ahead of AbbVie’s massive patent cliff for immunology blockbuster Humira in 2023, the company is busy launching next-gen drugs Rinvoq and Skyrizi. But that effort has hit a hurdle at the FDA—at least temporarily.
The agency extended its review on Rinvoq in psoriatic arthritis and raised additional questions in atopic dermatitis, too, threatening a much-anticipated challenge to Regeneron and Sanofi's Dupixent.
The FDA asked for additional information on Rinvoq’s risk-benefit profile in psoriatic arthritis, AbbVie said in its Wednesday release. The company has already sent its reply to the agency, but the FDA delayed its decision by three months to give it time to analyze the new info. A decision is now due late in the second quarter of this year.
The agency's follow-up queries come amid safety flags in the JAK inhibitor class. Pfizer's Xeljanz failed a recent post-marketing trial, raising new questions about the class' cardiovascular effects.
AbbVie remains “confident” in the application and is “committed to working with the FDA to bring [Rinvoq] to patients living with psoriatic arthritis and other immune-mediated diseases,” AbbVie president Michael Severino said in a statement.
If AbbVie scores an approval in psoriatic arthritis, its new entrant would face off against meds from Johnson & Johnson and Eli Lilly. Just this week, J&J touted two-year data on its Tremfya in the indication.
The agency also raised new questions about Rinvoq's application in atopic dermatitis, a closely watched bid to compete with Regeneron and Sanofi's Dupixent, which roared into the field a few years ago and has owned it ever since. AbbVie plans to submit additional information on that indication “shortly," the drugmaker said. It wasn't immediately clear if the agency's decision would be delayed in that use.
AbbVie's shares were trading down by around 6% on Wednesday morning, demonstrating that the news "clearly doesn’t sit well with investors," Piper Sandler analyst Christopher Raymond wrote to clients. But his team doesn't see the news as a major cause for concern.
The Piper Sandler team doesn't "believe this delay will significantly impact the drug’s long-term trajectory," Raymond wrote to clients.
AbbVie didn't disclose the nature of the FDA's questioning, but Raymond believes it stems from new safety flags on another JAK inhibitor, Pfizer's Xeljanz. After a postmarketing study identified new safety flags on that drug, Raymond believes the FDA wanted additional long-term safety data on the AbbVie medicine.
Bernstein analyst Ronny Gal and his team model $4 billion in peak sales between the indications, so the news will likely hang over the stock "until we learn more about where this is heading," Gal wrote to clients.
For his part, SVB Leerink analyst Geoffrey Porges said the news, combined with other recent developments at the FDA, suggests the agency is taking a tougher stance during drug reviews. Still, he believes Rinvoq's "strong efficacy data and tolerable safety profile support approval."
Rinvoq is already approved in rheumatoid arthritis and represents one-half of AbbVie's next-gen immunology franchise. Skyrizi, the other half, won its first approval in plaque psoriasis. AbbVie expects the duo of new immunology drugs to deliver $15 billion in sales by 2025.
Meanwhile, the company is bracing for biosimilar competition to its top drug, Humira. The company has inked a series of deals allowing biosimilar makers to launch in the U.S. throughout 2023. Humira is already facing biosimilar competition in Europe.
Ahead of Humira’s U.S. loss of exclusivity, AbbVie is working to score new uses for AbbVie and Skyrizi and put its full marketing muscle behind the drugs. Last year, the meds generated $2.3 billion combined.