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FDA approves Otezla for the treatment of patients with plaque psoriasis regardless of severity level.

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Last updated:21st Dec 2021
Published:21st Dec 2021
Amgen announced that the FDA has approved Otezla (apremilast) for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

With this expanded indication, Otezla is now the first and only oral treatment approved in adult patients with plaque psoriasis across all severities, including mild, moderate and severe.

The FDA approval is based on findings from the Phase III ADVANCE trial, in which five times as many adults with mild to moderate plaque psoriasis receiving oral Otezla 30 mg twice daily achieved the primary endpoint of Static Physician's Global Assessment (sPGA) response at week 16 compared to placebo (21.6% versus 4.1%, p<0.0001), a difference that was statistically significant. otezla also demonstrated statistically significant improvements in key symptoms, such as whole body itch nrs response (43.2% versus 18.6%), and a difficult-to-treat area, the scalp, measured by scalp physician's global assessment (scpga) response (44% versus 16.6%), at week 16 compared to placebo. improvements in spga response, whole body itch nrs and scpga response were observed as early as week 2 and maintained through week 32.

Otezla is approved for three indications in the U.S., including adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and for adult patients with oral ulcers associated with Behçet's Disease. Otezla is the most prescribed brand for plaque psoriasis patients starting systemic therapy.

Condition: Psoriasis
Type: drug

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