UPDATED: Incyte nabs approval of topical ruxolitinib in atopic dermatitis, but gets slapped with JAK warning
Incyte has made a pretty penny with its JAK inhibitor ruxolitinib over the years, but on Tuesday the drug crossed a new threshold.
The FDA approved a topical formulation of the drug for mild-to-moderate atopic dermatitis, Incyte announced Tuesday afternoon, giving the Wilmington, DE-based company a new arrow in its ruxolitinib quiver. The drug, which will be marketed as Opzelura, is the first topical JAK inhibitor approved in the US and is indicated for AD patients aged 12 and up who struggle to control their disease on other prescription creams.
“It can be hard for people to fully appreciate how difficult AD can be and the tremendous impact it has on patients,” said Julie Block, CEO of the National Eczema Association, in a statement. “The chronic itch is difficult to cope with and related sleep issues can be exhausting.”
An Incyte spokesperson told Endpoints News later Wednesday morning that the wholesale acquisition cost for Opzelura will be set at $1,950 per 60 gram tube.
Tuesday’s approval also came with the black box warning seen across the JAK class of drugs, highlighting risks of serious infections, heart attack, stroke or cardiac death.
Ruxolitinib has morphed into a blockbuster for Incyte since it garnered its first approval as an oral treatment for myelofibrosis back in 2011. The drug continued to rack up FDA endorsements ever since, getting nods for polycythemia vera in 2014 and acute graft-versus-host disease in 2019.
In these indications, the drug is marketed as Jakafi in the US and as Jakavi by Novartis elsewhere. Jakafi netted $995 million in revenue through the first half of 2021, maintaining some growth but also taking sales hits due to the Covid-19 pandemic, Incyte said.
But Incyte has been pushing to move ruxolitinib into a topical formulation for a while as well. By treating mild and moderate AD with a cream, patients can more easily treat their affected areas than with an oral drug. The topical formulation is also in development for vitiligo, another skin condition that can result in the loss of pigmentation.
The approval will also give Regeneron and Sanofi’s Dupixent some competition in the eczema field. Incyte is hoping it can advance Opzelura on ease of use, given that Dupixent is administered by injection. The company will have a tough task ahead, however, as Dupixent pulled in nearly $1.5 billion in sales in 2021’s second quarter alone.
At the very least, Incyte has hoped topical ruxolitinib can prove a more appealing alternative to corticosteroids, the standard of care in mild-to-moderate AD. Tuesday’s approval came on the basis of two Phase III studies that compared the cream to a placebo, with patients seeing at least a two-point improvement on an investigator assessment and a reduction in itch from baseline after eight weeks.
Peak sales estimates for the topical drug have ranged from $300 million to $1.1 billion by 2025.
This story has been updated with pricing information for Opzelura.