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Wednesday, Dec 6, 2023

Arcutis Gets FDA Nod For Plaque Psoriasis Cream

This article has been revised and corrected from the original version.

Westlake Village-based immune-dermatology company Arcutis Biotherapeutics Inc. has received federal approval to begin marketing its drug to treat plaque psoriasis in children ages 6 to 11. The company had already received approval to market the drug for use in people 12 and over.

Separately, the company this month announced a public offering of $100 million in shares and warrants to raise capital to fund the continued development, approval and commercialization of its multiple drug programs.

Arcutis’ main drug, called roflumilast, is a once-daily, steroid-free topical cream to manage plaque psoriasis, a skin immune-disease that involves  plaques – raised, red areas of skin covered with a silver or white layer of dead skin cells. Plaque psoriasis affects an estimated 9 million people in the United States.

Plaques in sensitive areas, where the skin may be thinner or more sensitive, have long posed specific treatment challenges. To address this, roflumilast is designed to be absorbed by the skin rapidly.

Also many of the treatments for plaque psoriasis involve creams that contain steroids, which are commonly used to control inflammation. But continual use of steroids can lead to other problems, including weight gain and increased risk of bruising. Arcutis’ roflumilast does not contain steroids.

Last year, the Food and Drug Administration approved the use of roflumilast in people ages 12 and over. Earlier this year, Arcutis filed a supplemental use application to expand the covered population to children ages 6 to 11.

As with most drugs with uses for this age cohort, this involved testing different dosing regimens that could be safely tolerated in children.

Patrick Burnett, chief medical officer for Arcutis, said in the announcement that there are fewer plaque psoriasis treatment drugs aimed at children.

“Young children with plaque psoriasis lack treatment options, which is why today’s decision by the FDA represents a meaningful advancement for this pediatric population, their parents, and caregivers,” Burnett said.

More specifically, in children, plaque psoriasis more often appears on sensitive areas including the face and skin folds, compared to adults, according to Adelaide Hebert, professor and chief of pediatric dermatology at McGovern Medical School at University of Texas Health in Houston. Roflumilast is specifically designed for use in these sensitive or thin-skinned areas.

As for the public offering, it was a mix of shares and pre-funded warrants doled out to specific shareholders who could then convert them into shares. Arcutis has already announced its intention to conduct this and other public offerings in a shelf registration statement filed in February 2021.

In its announcement of the pricing of the offering, Arcutis said it was selling 32.5 million shares of stock at $2.50 a share and pre-funded warrants priced at roughly $2.50 each that could be used to purchase 7.5 million shares.

The offering was initially announced on Oct. 19; the company said in its announcements that the offering period would close on Oct. 24. In the offering announcements, Arcutis laid out some of the specific uses for the approximately $100 million it expected to raise. These include potential launches of drugs to treat seborrheic dermatitis and atopic dermatitis and further expansions of covered patients suffering from various forms of psoriasis.

Morgan Stanley & Co., TD Cowen and Guggenheim Securities, a unit of Guggenheim Partners, acted as joint lead bookrunning managers for the offering.

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Hannah Madans Welk
Hannah Madans Welk
Hannah Madans Welk is a managing editor at the Los Angeles Business Journal and the San Fernando Valley Business Journal. She previously covered real estate for the Los Angeles Business Journal. She has done work with publications including The Orange County Register, The Real Deal and doityourself.com.

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