Amgen submits Otezla supplementary new drug application, indications extended to mild to moderate psoriasis

A few days ago, Amgen announced that it has submitted a supplementary new drug application (sNDA) for the oral drug Otezla (apremilast).

As early as 2014, Otezla was approved by the FDA for the treatment of adult patients with moderate to severe plaque psoriasis suitable for phototherapy and systemic therapy.

The ADVANCE (PSOR-022) trial is a phase 3, multi-center, randomized, placebo-controlled, double-blind study that mainly evaluated Otezla in mild to moderate plaque psoriasis (BSA accounts for 2% to 15%).

The results of the test showed that compared with placebo, at week 16, the sPGA skin score of patients who applied 30 mg of Otezla twice a day achieved a statistically significant improvement, and the test reached the primary endpoint.

Otezla is an oral, selective phosphodiesterase 4 (PDE4) inhibitor, the drug is the first and only PDE4 inhibitor approved by the FDA for the treatment of plaque psoriasis.

Otezla was originally a blockbuster drug developed by Xinji.

Otezla is currently approved in the United States for 3 indications, including the treatment of patients with moderate to severe plaque psoriasis suitable for phototherapy or systemic therapy, adults with active psoriatic arthritis, and oral ulcers associated with Behcet's disease Adult patients.

In November last year, in a phase 3 key clinical trial of POETYK PSO-1 for patients with moderate to severe plaque psoriasis, the efficacy of Bristol-Myers Squibb TYK2 inhibitor deucravacitinib surpassed that of Otezla.