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Dermavant Wins FDA Approval for Topical Cream Therapeutic to Treat Plaque Psoriasis

Dermavant Sciences Inc., a Long Beach-based biopharmaceutical company developing drugs to treat skin diseases and conditions, announced on May 24 that it had received U.S. Food & Drug Administration approval for a topical cream to treat plaque psoriasis in adults.

The company said it could have its prescription drug cream, marketed under the brand name VTAMA, in distribution channels as early as next week and available for prescriptions shortly thereafter. The company noted that its cream is the first and – so far at least –only FDA-approved non-steroidal topical medication for treatment of plaque psoriasis.

For Dermavant, the FDA approval caps a four-year effort to bring the drug, known as tapinarof, to market. In 2018, the company purchased the rights to the drug from London-based pharmaceutical giant GlaxoSmithKline in a deal valued in press reports at the time at nearly $354 million.

Dermavant itself is a wholly owned subsidiary of Basel, Switzerland-based Roivant Sciences. Roivant trades on the Nasdaq and had a market cap of $2.7 billion as of May 24.
“We are delighted with our FDA-approved label for VTAMA cream, which is for adults with psoriasis, regardless of disease severity, and with an unlimited duration of use,” Todd Zavodnick, Dermavant’s chief executive, said in the announcement. “In anticipation of today’s approval, we have a fully built commercial infrastructure in place, and I am excited to say we will have product in the channel in the first week of June,” he continued. “The FDA’s approval of VTAMA cream provides an effective new non-steroidal treatment option for millions of adults living with plaque psoriasis and represents a major milestone for Dermavant and its stakeholders.”

Psoriasis is an autoimmune disease impacting about 8 million Americans and 125 million people worldwide. Plaque psoriasis is the disease’s most common form; it is characterized by raised patches of skin with silvery-white scale that can be very itchy.

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