Pfizer and Lilly Receive FDA Fast Track Designation for Tanezumab
- Global Phase 3 program is studying potential new treatment option for millions of people living with chronic pain associated with osteoarthritis and chronic low back pain
- Acts in a different manner than opioids and other analgesics
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"If approved, tanezumab would be the first in a new class of non-opioid
chronic pain medications," said
The Phase 3 global clinical development program for tanezumab is currently ongoing and includes six studies in approximately 7,000 patients with OA, CLBP 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.
"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
For more information on ongoing clinical trials of tanezumab, visit www.clinicaltrials.gov.
Tanezumab is an investigational humanized monoclonal antibody, which works by selectively targeting, binding to and inhibiting NGF. NGF levels increase in the body as a result of injury, inflammation or in chronic pain states. By inhibiting NGF, tanezumab may help to keep pain signals produced by muscles, skin and organs from reaching the spinal cord and brain. Tanezumab has a novel mechanism that acts in a different manner than opioids and other analgesics, including nonsteroidal anti-inflammatory drugs (NSAIDs).
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.
PFIZER DISCLOSURE NOTICE: The information contained in this
release is as of
This release contains forward-looking information about a product candidate, tanezumab, including its potential benefits that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including, without limitation, the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; whether and when new drug applications may be filed in any jurisdictions for tanezumab; whether and when such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of tanezumab; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer's Annual Report on Form 10-K for the fiscal year ended
LILLY DISCLOSURE NOTICE: This press release contains
forward-looking statements (as that term is defined in the Private
Securities Litigation Reform Act of 1995) about tanezumab as a potential
treatment for patients with osteoarthritis, chronic low back pain, and
cancer pain, and reflects Lilly's current beliefs. However, as with any
pharmaceutical product, there are substantial risks and uncertainties in
the process of drug development and commercialization. Among other
things, there is no guarantee that future study results will be
consistent with study findings to date, or that tanezumab will be
approved by the
Eli Lilly Media:
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