The US Food and Drug Administration (FDA) has given the green light to a drug to treat the skin condition seborrheic dermatitis in patients from as young as nine-years-old.
The regulator’s approval of the medication, from Arcutis Biotherapeutics, makes roflumilast foam the first topical drug for treating moderate to severe seborrheic dermatitis with a new mechanism of action in more than two decades, reports Reuters.
Seborrheic dermatitis, a common, chronic and recurrent inflammatory skin disease, affects more than 10m people in America, Arcutis said.
The drug is a foam-based formulation of the company’s roflumilast cream 0.3%, sold as Zoryve, which is approved as a topical treatment of plaque psoriasis in patients six years and older.
The drug met its primary study goal in the late-stage trial with a success rate of 79.5% on the five-point assessment scale compared with 58.0% in those treated with the vehicle, which is similar to a placebo.
The formulation, designed to overcome the challenges of delivering topical drugs in hair-bearing areas of the body, also showed meaningful improvement over the vehicle arm in disease symptoms, including itch, scaling and redness.
Arcutis said it planned to commercially launch Zoryve by the end of January.
Reuters article – US FDA approves Arcutis drug to treat chronic skin disease (Open access)
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