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Seborrheic dermatitis is a common skin condition that causes scaly patches, inflamed skin and stubborn dandruff on oily areas of the body like the face, eyebrows or chest, according to the Mayo Clinic.
The disease impacts over 10 million people in the U.S., California-based Arcutis said.
In a statement released following the close of trading on Friday, the company noted the FDA has made its once-daily roflumilast topical foam — known as Zoryve — the first drug approved for seborrheic dermatitis “with a new mechanism of action” in more than two decades. The commercial product is expected to be made available by the end of January, the company added.
Arcutis said a late-stage trial found that Zoryve met its primary efficacy goal, with a success rate of 79.5% on a 5-point assessment scale. A vehicle similar to a placebo was shown to have a success rate of 58%.
Chief Commercial Officer Todd Edwards has said that two of the top three U.S. pharmacy benefit managers are projected to cover the product, Reuters reported.
