Arcutis, with Amgen in its crosshairs, seeks FDA approval for topical psoriasis drug

scrabble tiles spelling out psoriasis
Faced with stiff competition, Arcutis has pointed to the size and speed of the effects of its candidate as differentiators. (Alpha Stock Images CC-BY-SA 3.0)

Arcutis Biotherapeutics has taken another step toward challenging Amgen for the plaque psoriasis market. With the FDA submission now in, Arcutis is nearing the approval of its topical spin on an oral AstraZeneca product. 

The filing is based on phase 3 trials that found roflumilast, a topical formulation of the PDE4 inhibitor found in AstraZeneca’s chronic obstructive pulmonary disease treatment Daliresp, is better than placebo at reducing the severity of plaque psoriasis in patients with mild-to-severe forms of the skin condition.

If roflumilast wins approval, Arcutis will face the challenge of persuading the market that its drug is a better therapy than other options. Roflumilast is on track to become the first topical PDE4 inhibitor approved in the indication but drugs with other mechanisms of action are available.

Amgen’s blockbuster Otezla is well established and Arcutis is one of several challengers to the drug. Dermavant’s tapinarof is just ahead of roflumilast in the queue at the FDA, with the agency accepting an application for the candidate last month, and Bristol Myers Squibb is aiming to launch its prospect deucravacitinib next year on the strength of clinical trials in which it beat Otezla.

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Faced with stiff competition, Arcutis has pointed to the size and speed of the effects of its candidate and the potential for chronic use across the body as potential differentiators from the competition. 

“Individuals with plaque psoriasis currently do not have topical treatment options that offer a combination of good tolerability and the ability to be used for long periods of time, and that can be used on all parts of the body,” Arcutis CEO Frank Watanabe said in a statement. Watanabe is pitching roflumilast as the drug to fill that gap in the market.