Amgen Submits Supplemental NDA for Mild-to-Moderate Psoriasis Drug Otezla

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Amgen has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for its adult mild-to-moderate plaque psoriasis treatment, Otezla® (apremilast), according to a statement released by the company today.

Otezla, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) directed for cyclic adenosine monophosphate (cAMP), may indirectly modulate inflammatory mediators in certain conditions, but the specific underlying mechanisms are not clearly understood.

The therapy is currently indicated for adult patients with moderate to severe plaque psoriasis who are eligible for phototherapy or systemic therapy. In addition, Otezla is approved for the treatment of adults with active psoriatic arthritis as well as for adults with oral ulcers associated with Behçet's Disease. Outside the U.S., the drug is approved in more than 50 markets and features a patent protection through 2028 in the U.S.

Amgen’s new sNDA is based on Phase III data from the ADVANCE trial. These data show that twice-daily oral Otezla 30 mg was associated with a significant improvement in the 16-week primary endpoint of the static Physician's Global Assessment (sPGA) response compared with placebo.

"Despite treatment advances, there remains an unmet need for people with clinically mild-to-moderate plaque psoriasis who use existing topical therapies and still have challenges managing their disease, particularly those with disease in hard-to-treat locations,” said Amgen’s executive vice president of Research and Development David M. Reese, M.D. “Results from the ADVANCE trial demonstrated the potential of Otezla to provide an oral, non-biologic option for these patients. We look forward to working with the FDA to potentially expand access to Otezla and deliver on our commitment to improve outcomes for people living with mild-to-moderate plaque psoriasis."

In the ADVANCE trial, treatment with Otezla was also associated with significantly greater improvements in key secondary endpoints when compared with placebo. These endpoints included achievement of at least a 75% improvement in the percent of affected body surface area (BSA) from baseline as well as the change in BSA total score and change in Psoriasis Area and Severity Index (PASI) total score from baseline to week 16.

Adverse events associated with Otezla or placebo in at least 5% of patients in the Phase III trial included diarrhea, headache, nausea, nasopharyngitis and upper respiratory tract infection. All AEs associated with Otezla in the trial were consistent with those reported in previous research, the company said. Amgen plans on submitting the results from the trial for presentation at a future meeting.

Otezla represents a major driver in the company’s autoimmune portfolio. In November 2019, Amgen acquired the therapy from Celgene for moderate-to-severe plaque psoriasis and psoriatic arthritis to a tune of $13.4 billion. During this time, Bristol Myers Squibb acquired Celgene and was made to divest the therapy by the U.S. Securities and Exchange Commission (SEC) due to a competing pipeline product, deucravacitinib (BMS-986165).

In November of last year, deucravacitinib was superior to Otezla for one of the key secondary endpoints in the Phase III POETYK PSO-1 trial, but the drug otherwise met the co-primary endpoints on psoriasis.

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