Pfizer and Lilly receive FDA Fast Track designation for tanezumab

PfizerPfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for tanezumab for the treatment of chronic pain in patients with osteoarthritis (OA) and chronic low back pain (CLBP). Tanezumab 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, a process designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs.

"If approved, tanezumab 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."

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 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."

About Tanezumab
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).

In 2013, Pfizer and Lilly entered into a worldwide co-development and co-commercialization agreement for the advancement of tanezumab.

Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.

About Eli Lilly and Company
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.

Most Popular Now

A need for bananas? Dietary potassium regulates ca…

Bananas and avocados - foods that are rich in potassium - may help protect against pathogenic vascular calcification, also known as hardening of the arteries. University ...

FDA awards 15 grants for clinical trials to stimul…

The U.S. Food and Drug Administration today announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to...

Amgen and CytomX Therapeutics announce strategic c…

Amgen (NASDAQ:AMGN) and CytomX Therapeutics, Inc., (NASDAQ:CTMX) today announced that the companies have entered into a strategic collaboration in immuno-oncology. The co...

Novartis and The Max Foundation transform pioneeri…

Novartis announced a new collaboration with The Max Foundation to support continued access to treatment at no cost for nearly 34,000 current patients with chronic myeloid...

Roche launches NAVIFY Tumor Board solution to prov…

Roche (SIX: RO, ROG; OTCQX:RHHBY), has announced the launch of the NAVIFY Tumor Board solution, a clinical workflow and decision support software that optimises decision-...

AbbVie and Bristol-Myers Squibb announce clinical …

AbbVie (NYSE: ABBV) and Bristol-Myers Squibb Company (NYSE: BMY) today announced a clinical trial collaboration to evaluate the combination of AbbVie's investigational an...

Tagrisso granted breakthrough therapy designation …

AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatm...

Pfizer launches novel programs to put important su…

Pfizer today unveils enhanced offerings to help patients manage their life with cancer. Pfizer Oncology Together is a first-of-its-kind program for patients taking Pfizer...

Novartis and UC Berkeley collaborate to tackle 'un…

Novartis has joined forces with researchers from the University of California, Berkeley, to develop new technologies for the discovery of next-generation therapeutics, pu...

Printed meds could reinvent pharmacies, drug resea…

A technology that can print pure, ultra-precise doses of drugs onto a wide variety of surfaces could one day enable on-site printing of custom-dosed medications at pharma...

Danish discovery can pave the way for more effecti…

More than 600,000 Danes are being treated with cholesterol lowering medicine. 98 per cent of them are treated with statins, which curb the body's own production of choles...

Amgen and Simcere announce strategic collaboration…

Amgen (NASDAQ: AMGN) and Simcere Pharmaceutical Group have announced the execution of an exclusive agreement to co-develop and commercialize four biosimilars in China. Th...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]