(Reuters) – AbbVie Inc said on Tuesday that the U.S. Food and Drug Administration approved its Skyrizi drug as a treatment for plaque psoriasis at a time when its blockbuster psoriasis drug, Humira, faces patent pressures.
Plaque psoriasis is the most common form of psoriasis, a chronic skin condition.
The approval of Skyrizi, an injectable drug, is based on results from AbbVie’s global Phase 3 psoriasis program, which assessed the safety and efficacy of the drug in adults with moderate to severe plaque psoriasis.
AbbVie said it expects Skyrizi to be available in the United States in early May.
Psoriasis causes an overproduction of skin cells, resulting in inflamed, red lesions or plaques, which can be itchy and painful. It affects 7.5 million Americans and is the most prevalent autoimmune disease in the United States, AbbVie said.
Humira is the world’s best-selling prescription medicine and has long buoyed AbbVie’s business, bringing in revenue of $19.94 billion in 2018. But it is set to face biosimilar competition from 2023.
Skyrizi, which won regulatory approval in Canada and Japan earlier this year, is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of the drug.
APRIL 24, 2019