Regulatory Affairs

Pfizer, Eli Lilly get FDA fast track status for chronic pain drug Tanezumab

PBR Staff Writer Published 14 June 2017

Pfizer and Eli Lilly have secured fast track status from the US Food and Drug Administration (FDA) for tanezumab to treat chronic pain in patients with osteoarthritis (OA) and chronic low back pain (CLBP).

Tanezumab is an investigational humanized monoclonal antibody, which can selectively target, bind and inhibit nerve growth factor (NGF).

Through inhibiting NGF, tanezumab will enable to prevent pain signals produced by muscles, skin and organs from reaching the spinal cord and brain.

In 2013, Pfizer and Lilly signed a worldwide co-development and co-commercialization agreement to advance the development of tanezumab.

Currently, the phase 3 global clinical development program is ongoing for tanezumab, which is comprised of six studies.

The trials include around 7,000 patients with OA, CLBP or cancer pain who did not get adequate pain relief with approved therapies.

During the studies, subcutaneous administration of tanezumab will be done by health care providers once every eight weeks for treatment periods ranging from 16 to 56 weeks, followed by a 24-week safety follow-up period.

Results from the studies are expected to be revealed in 2018.

Pfizer neuroscience and pain global product development chief development officer Ken Verburg said: “If approved, tanezumab would be the first in a new class of non-opioid chronic pain medications."

Lilly Bio-Medicines president and senior vice president Christi Shaw said: "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.”

In March, Pfizer along with Merck’s EMD Serono secured FDA approval for Bavencio (avelumab) injection 20 mg/mL to treat metastatic Merkel cell carcinoma (mMCC).

Bavencio, which is developed for intravenous use, was approved to treat adults and pediatric patients aged 12 years and older with mMCC.

Image: Pfizer world headquarters in Manhattan, New York. Photo: courtesy of Coolcaesar.