Posted by Michael Wonder on 02 Mar 2020
U.S. FDA accepts regulatory submission for tanezumab, a potential first-in-class treatment for patients with chronic pain due to moderate-to-severe osteoarthritis
2 February 2020 - Pfizer and Eli Lilly today announced that the U.S. FDA accepted for review a Biologics License Application for tanezumab 2.5 mg administered subcutaneously, which is being evaluated for patients with chronic pain due to moderate-to-severe osteoarthritis who have experienced inadequate pain relief with other analgesics.
Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor inhibitors.
The Prescription Drug User Fee Act goal date for the FDA to make a decision on the tanezumab application is in December 2020. In its acceptance letter, the FDA stated that it is currently planning to hold an Advisory Committee meeting to discuss this application.
