Arcutis: Health Canada Accepts NDS For Roflumilast Cream To Treat Plaque Psoriasis

(RTTNews) - Arcutis Canada Inc., a unit of medical dermatology company Arcutis Biotherapeutics, Inc. (ARQT), announced Monday that Health Canada has accepted the New Drug Submission or NDS for roflumilast cream 0.3% (ARQ-151) to treat plaque psoriasis in adults and adolescents.

The company noted that the safety and efficacy of roflumilast cream remain under investigation, and market authorization in Canada has not yet been obtained.

If approved by Health Canada, roflumilast will be an important new treatment option for people suffering from psoriasis, a chronic inflammatory skin condition. Plaque psoriasis is its most common form.

Roflumilast cream is a once-daily topical formulation of roflumilast, an inhibitor of phosphodiesterase type 4 or PDE4, an enzyme that drives overactive immune responses and is an established target in dermatology.

The Arcutis NDS is supported by clinical trial results from Arcutis' pivotal Phase 3 program and two long-term open label studies, DERMIS 1 and DERMIS 2.

Jamie Lewis, Head of Arcutis Canadian operations, said, "This is a major milestone for Arcutis in Canada and an important step towards potentially bringing an alternative topical option to market for plaque psoriasis that has been developed for chronic use anywhere on the body, including sensitive areas such as the face, genitals and in areas where the skin rubs together."

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