Abbott seeks approval for Humira in psoriasis

USA-based health care major Abbott Laboratories says that it has filed a supplemental Biologics License Application with the Food and Drug Administration, as well as a Type II Variation with the European Medicines Agency (EMEA), requesting approval to sell Humira (adalimumab) as a treatment for moderate-to-severe plaque psoriasis.

Currently, the drug is cleared by the EMEA and the FDA for the treatment of a range of immune-mediated diseases, including rheumatoid and psoriatic arthritis and ankylosing spondylitis (Marketletters passim). Psoriasis is a non-contagious chronic autoimmune disease that is characterized by the development of red lesions, or plaques. The condition is thought to affect around 125 million people worldwide.

Impressive results in pivotal Ph III studies