FDA approves roflumilast cream for plaque psoriasis
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The FDA has approved Zoryve cream for the treatment of plaque psoriasis, Arcutis announced in a press release.
A nonsteroid, phosphodiesterase-4 inhibitor, Zoryve (roflumilast cream 0.3%) is a once-daily topical treatment for psoriasis and the first PDE4 inhibitor approved for this indication.
“For decades the leading psoriasis products have been topical steroids,” Mark G. Lebwohl, MD, dean of clinical therapeutics and chair emeritus of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, and a lead investigator of the roflumilast clinical trials, told Healio. “The drawback of steroids is, if used chronically, they stop working and they thin the skin.”
Zoryve is the first product approved that has shown no irritation or thinning of the skin, allowing it to be used continuously, chronically and in intertriginous areas.
“It is well tolerated, not painful or irritating at all and it doesn’t thin the skin,” Lebwohl said. “It’s a very benign treatment. It is one cream that patients can use everywhere — on the face, the groin or all over the body.”
The approval was based on results of the phase 3, randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center DERMIS1 and DERMIS2 studies, in which roflumilast cream attained its primary endpoint of an IGA success rate of 46.4% vs. 6.1% in vehicle and 37.5% vs. 6.9% in vehicle (both, P < .0001), respectively.
“Our safety profile has really shown that even up to over 52 weeks of treatment, patients have a really good local tolerability profile — meaning they are not getting local side effects causing discontinuation,” Patrick Burnett, MD, PhD, chief medical officer of Arcutis, told Healio. “We are super excited this will be available to patients. I think the field in general has been really looking for the ability to treat patients with psoriasis without a steroid.”
The company plans to have the product available by mid-August and a patient support program titled The Zoryve Direct will assist in supplying Zoryve with affordable access, according to the press release.
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