FDA fast-tracks Pfizer and Lilly’s chronic pain drug
pharmafile | June 15, 2017 | News story | Research and Development, Sales and Marketing | Eli Lilly, FDA, Pfizer
Pfizer and Eli Lilly are celebrating the FDA’s decision to grant fast-track designation to their joint venture tanezumab in the treatment of chronic low back pain (CLBP) and pain in osteoarthritis (OA) patients.
The drug is a selective investigational humanised monoclonal antibody which targets and inhibits nerve growth factor – the first of its kind to receive such designation. The decision was based on an ongoing Phase 3 trial of around 7,000 patients suffering from pain related to CLBP, OA or cancer who had not seen relief following the use of approved therapies. Tanezumab is administered subcutaneously once every eight weeks for up to 56 weeks. Full results of the study are expected next year.
“If approved, tanezumab would be the first in a new class of non-opioid chronic pain medications,” said Pfizer’s Ken Verburg, Chief Development Officer, Neuroscience & Pain, 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.”
Christi Shaw, Senior Vice President and President at Lilly Bio-Medicines added: “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. 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.”
Matt Fellows
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