Westlake Village-based immunodermatology firm Arcutis Biotherapeutics Inc. has acquired approval from the Meals and Drug Administration for a topical foam model of its primary drug to deal with seborrheic dermatitis in people aged 9 and older. The approval, introduced final month, marks the primary new methodology of utility for a drug to deal with seborrheic dermatitis in additional than 20 years.
Seborrheic dermatitis is a continual recurrent inflammatory pores and skin illness that impacts greater than 10 million folks in america. In most individuals, it’s marked by purple patches lined with massive, greasy, flaking yellow-gray scales, and protracted itch. It happens most frequently in areas of the physique with oil-producing glands, together with the scalp, face, higher chest, and again. Hair-bearing areas make making use of topicals like lotions, gels and ointments tough.
Arcutis’ breakthrough drug roflumilast is a phosphodiesterase-4 inhibitor that will increase the physique’s manufacturing of 1 enzyme that blocks the physique’s irritation response and reduces manufacturing of one other enzyme that reinforces the physique’s irritation response. In July 2022, the FDA accredited a cream formulation of the drug, which is marketed underneath the title Zoryve, to deal with plaque psoriasis in sufferers age 6 and older.
However topical lotions are exhausting to use in areas of the physique which have lots of hair or are exhausting to succeed in. That prompted Arcutis to develop a foam that makes use of a propellant to allow the drug to be utilized in hard-to-reach locations. This enables the drug for use for seborrheic dermatitis, which regularly thrives in these areas.
“We’re thrilled with this FDA approval and are excited to convey to market a brand new, extremely efficient steroid-free topical formulation that can be utilized anyplace on the physique,” mentioned Frank Watanabe, chief govt of Arcutis. “Our business crew is prepared and poised to launch Zoryve foam very quickly, and we’re dedicated to making sure reasonably priced entry to Zoryve foam to those that might profit from this novel remedy.”
Originally posted 2024-01-15 08:01:47.