New Nerve Growth Factor Inhibitor Submitted to FDA

A novel non-opioid chronic pain medication has been submitted to the FDA under the Biologic License Application (BLA) rules by New York-based Pfizer Inc. and Indianapolis, Indiana-based Eli Lilly and Company.

The new drug, tanezumab 2.5 mg would eventually be commercialized as a non-opioid chronic pain inhibitor for patients with chronic pain due to moderate-to-severe osteoarthritis (OA). Tanezumab is administered subcutaneously (SC). Furthermore, the drug is meant for patients who have gotten little or no pain relief with other analgesics.

Pfizer described tanezumab as “a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF) inhibitors.” The submission involves data from 39 Phase 1-3 clinical studies which evaluated the safety and efficacy of tanezumab in more than 18,000 patients (including three Phase 3 studies evaluating SC administration of tanezumab in patients with moderate-to-severe OA).

“The FDA acceptance of the tanezumab application represents a significant milestone, and the breadth of our regulatory submission reflects the extensive clinical data we have gathered for tanezumab over the course of its development,” said Ken Verburg, tanezumab development team leader, Pfizer Global Product Development.

“There is an urgent need for innovation in the treatment of osteoarthritis, as there have been no new classes of medicines available for this debilitating condition in more than a decade. If approved, tanezumab would be a first-in-class treatment for patients suffering from chronic pain due to moderate-to-severe osteoarthritis who have experienced inadequate pain relief with other analgesics.”

“Osteoarthritis patients face a significant burden—due to the physical pain they experience, nearly every aspect of their lives can be impacted. This pain can affect their ability to participate in daily activities, which can have significant psychological, social and societal consequences,” said Patrik Jonsson, president, Lilly Bio-Medicines. “We look forward to working closely with the FDA to potentially bring tanezumab to patients living with moderate-to-severe osteoarthritis.”

Ken Verburg described the next steps to OTW: “We look forward to continuing to work closely with the FDA as they review the submission over the coming months. We continue to see high unmet need in osteoarthritis. In fact, there are an estimated 27 million Americans living with osteoarthritis, 11 million of whom have moderate-to-severe osteoarthritis. Many are cycling through therapies without relief. We believe tanezumab has the potential to be an important first-in-class, non-opioid treatment option for patients suffering from chronic pain due to moderate-to-severe osteoarthritis who have experienced inadequate pain relief with other analgesics.”