The Food and Drug Administration (FDA) recently accepted for review a Biologics License Application (BLA) for Amgen's ABP 501, a possible treatment for inflammatory diseases.
ABP 501 is an anti-tumor necrosis factor-alpha monoclonal antibody, similar in pharmaceutical dosage and strength to adalimumab.
"If approved, we believe ABP 501 could serve as an important additional approved therapeutic option for patients with chronic inflammatory conditions," Sean Harper, executive vice president of research and development at Amgen, said. "We look forward to potentially expanding our robust portfolio of approved products and further demonstrating our continued commitment to delivering high-quality medicines to patients worldwide."
Submitted Nov. 25, 2015, the BLA is based on Phase III studies of the effect it had on moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The testing demonstrated that ABP 501 had effectiveness and safety ratings comparable to adalimumab.
The target action date for the BLA is Sept. 25.