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Tanezumab Gets Fast Track Designation From FDA for Chronic Pain Conditions

June 14, 2017
Pfizer and Lilly announced that tanezumab, a human monoclonal antibody, has received fast track designation from the Food and Drug Administration.

Update: March 2021 – An FDA Joint Advisory Committee voted against the BLA submitted by Pfizer and Eli Lilly for tanezumab for the treatment of osteoarthritis pain, noting that its risks did not outweight the investigational drug's benefits.


The US Food and Drug Administration (FDA) has granted Fast Track designation for tanezumab for the treatment of chronic pain in patients with osteoarthritis  and chronic low back pain, according to a statement released by Pfizer and Lilly.1

Tanezumab (RN624) is an investigational humanized monoclonal antibody that selectively targets, binds to, and inhibits nerve growth factor (NGF). "It is the first NGF inhibitor to receive Fast Track designation," noted the press release. "If approved, it would be the first in a new class of non-opioid chronic pain medications," said Ken Verburg, Chief Development Officer, Neuroscience & Pain, Pfizer Global Product Development. "We believe it would represent an important medical advance in the treatment of debilitating osteoarthritis and chronic low back pain for patients who do not experience adequate pain relief or cannot tolerate currently available pain medications."2

Rocky Road to Fast Track

It has not been a smooth road for tanezumab, however. In earlier Phase 3 studies, the incidence of rapidly progressive OA was found to be higher in patients taking the 10 mg tanezumab dose compared with patients on nonsteroidal anti-inflammatory drugs (NSAIDs), and rapidly progressive OA was more likely when tanezumab was given in combination with an NSAID.2

In June 2010, the FDA "placed a hold" on the development program for osteoarthritis and chronic low back pain programs.3 In December, 2010, all active studies for anti-NGF agents were placed on hold because of reports of suspected osteonecorisis, which required total knee replacement.3 In August 2012, the FDA's Arthritis Advisory Committed lifted the clinical hold on anti-NGF agents in a vote of 20 to 1, and allowed the development of tanezumab.4

According to MedPage Today, the FDA again placed a hold in December 14, 2012. In an interview with MedPage Today, Pfizer spokesperson noted that "The partial clinical hold was based on peripheral nervous system effects observed in animal studies conducted with nerve growth factor inhibitors by other companies. Current and future studies of tanezumab in cancer pain are not affected by this partial clinical hold."2

In March, 2015. Pfizer and Lilly announced that they were to resume Phase 3 chronic pain program for tanezumab.5 "This announcement follows a decision by the FDA to lift the partial clinical hold on the tanezumab development program after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab," said the press release. 

Current Trial Moving Forward

The current Phase 3 global clinical development program for tanezumab is currently ongoing and includes 6 studies in approximately 7,000 patients with osteoarthritis, chronic low back pain, or cancer pain who did not experience adequate pain relief with approved therapies. "Results are projected to begin reporting out in 2018. All studies are investigating subcutaneous administration of tanezumab by a health care provider once every eight weeks for treatment periods ranging from 16 to 56 weeks, followed by a 24-week safety follow-up period."1

"It is estimated that there are more than 27 million Americans currently living with osteoarthritis and 23 million living with chronic low back pain, many of whom fail to achieve adequate pain relief despite treatment with various types of pain medications," said Christi Shaw, Senior Vice President and President, Lilly Bio-Medicines. "We are committed to offering innovative solutions to people suffering from chronic pain conditions, and look forward to working closely with the FDA to facilitate the development of tanezumab."

Common Adverse Reactions

According to the FDA,3 common adverse reactions seen in clinical trials include:

  • Neurosensory symptoms
  • Arthralgia
  • Pain in extremity
  • Peripheral edema
  • Joint-related events, including joint replacement, osteonecrosis, rapid joint destruction, and atraumatic fractures.

Joint-related events appear to be "a dose response."3


Last updated on: April 8, 2021
Continue Reading:
Common osteoarthritis treatment may get radical makeover

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