Lilly, Pfizer Drug Lands FDA Designation
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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowIndianapolis-based Eli Lilly and Co. (NYSE: LLY) and New York-based Pfizer Inc. (NYSE: PFE) have received a Fast Track designation from the U.S. Food and Drug Administration for a drug currently undergoing a Phase 3 clinical trial. Tanezumab is being developed for the treatment of chronic pain in patients with osteoarthritis and chronic low back pain.
Lilly says the drug is part of an ongoing Phase 3 global clinical development program which includes six studies involving about 7,000 patients. The companies expect to begin reporting results in 2018.
"If approved, tanezumab would be the first in a new class of non-opioid chronic pain medications," said Ken Verburg, chief development officer, neuroscience and pain for 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."
The Fast Track designation aims to "facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs," according to Lilly.