The Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) will examine data supporting Amgen biotechnoloy company’s Biologics License Application (BLA) for ABP 501.
The compound is a biosimilar candidate to Humira (adalimumab), an anti-tumor necrosis factor-alpha monoclonal antibody targeting autoimmune diseases including rheumatoid arthritis. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (U.S.) and adalimumab (EU).
“With our heritage in both rheumatology and dermatology, we are committed to providing physicians and patients a variety of biologic options, which are critical for the long-term management of these serious diseases,” said Dr. Sean E. Harper, executive vice president of Research and Development at Amgen in a press release. “We look forward to discussing the comprehensive data package for ABP 501 with the members of the Committee.”
In January, the FDA accepted ABP-501 BLA for review; a Biosimilar User Fee Act target action date was set for Sept. 25. The FDA’s Arthritis Advisory Committee will review pharmacokinetic and clinical data evaluating the compound which includes data from two Phase 3 comparative safety and efficacy trials in patients with moderate-to-severe rheumatoid arthritis and moderate-to-severe plaque psoriasis.
Both trials met outcomes designed to show equivalence to adalimumab. The data from both trials also demonstrated a comparable safety profile between ABP 501 and adalimumab. The Company’s submission also includes data to support the transition of adalimumab patients to ABP 501.
Behavioral intervention that combines text message reminders and counseling sessions to encourage physical activity is leading to better health for rheumatoid arthritis (RA) patients. The intervention was found to decrease daily sitting time by more than two hours and reduce cholesterol levels. Sedentary behavior is most prevalent in industrialized countries. Objective measurements of physical activity in patients with RA reveals they spend much of the day sitting, laying down, sleeping, or otherwise relaxing. Evidence shows that too much “relaxing” is associated with increased risk of cardiovascular diseases, obesity, Type 2 diabetes and other disease. Patients with RA are known to be at higher risk of cardiovascular disease.
