Research & Development
Amgen submits US FDA supplemental New Drug Application for Otezla
23 February 2021 -

United States-based Amgen (NASDAQ:AMGN) announced on Monday that it has submitted a supplemental New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Otezla (apremilast) intended for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy.

The company has submitted the supplemental NDA based on data from the Phase three ADVANCE trial that indicated oral Otezla 30mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician's Global Assessment response at week 16 compared to placebo.

David M Reese, MD, executive vice president of Research and Development at Amgen, said, '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. 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.'

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