- Amgen (AMGN +0.3%) announced the submission of a supplemental New Drug Application ((sNDA )) to the U.S. FDA for Otezla (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy.
- The sNDA is based on data from the Phase 3 ADVANCE trial that showed oral Otezla 30 mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician's Global Assessment ((sPGA)) response at week 16 compared to placebo.
- Results from the ADVANCE trial showed the potential of Otezla to provide an oral, non-biologic option for the disease space.
- In the U.S., Otezla is approved for the treatment of adult patients with moderate-to-severe 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.