The United States Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) granted these designations based on the topline results from the EFFISAYIL™ 2 trial.
The European Commission has approved Sotyktu™ (deucravacitinib) in European Union.
Amgen receives approval from the United States Food and Drug Administration (FDA) for AMJEVITA™, a biosimilar for adults with psoriasis and psoriatic arthritis.
This announcement follows the September 2022 approval from the U.S. Food and Drug Administration (FDA) and the Japan’s Ministry of Health, Labour, and Welfare.
European Commission grants conditional marketing authorization based on the EFFISAYIL® 1 trial, which showed over half of the spesolimab-treated patients were free of pustules, one week after receiving a single dose. This decision builds on existing approvals in the United States and Japan.
Sotyktu™(deucravacitinib), an oral treatment for adults with moderate to severe plaque psoriasis. Sotyktu™ is the only approved TYK2 inhibitor worldwide and the first improvement in oral treatment for moderate to severe plaque psoriasis in nearly ten years.
Eli Lilly announced a new formula for Taltz® that contains the same active ingredient as the original formulation, but patients experience significantly less pain at the injection site.
ZORYVE is the first and only topical phosphodiesterase-4 (PDE4) inhibitor approved to treat plaque psoriasis. The product is expected to be available mid-August.
Dermavant announced the FDA approval for VTAMA® (tapinarof) cream, 1% for the Treatment of Plaque Psoriasis in Adults. This is the first topical novel chemical entity launched for psoriasis in the U.S. in 25 years.
