Pfizer and Eli Lilly Report the US FDA Acceptance of BLA for Tanezumab to Treat Chronic Pain Due to Moderate-to-Severe Osteoarthritis

Pfizer and Eli Lilly Report the US FDA Acceptance of BLA for Tanezumab to Treat Chronic Pain Due to Moderate-to-Severe Osteoarthritis

Shots:

  • The US FDA has accepted to review a BLA for tanezumab (2.5 mg, SC), being evaluated for patients with chronic pain due to mod. to sev. OA with inadequate pain relief with other analgesics
  • The regulatory submission is based on data from 39 P-I-III clinical studies assessing tanezumab in 18,000 patients, including three P-III studies evaluating tanezumab (SC) in patients with mod. to sev. OA
  • Tanezumab is an investigational mAb targeting & inhibiting NGF with its anticipated PDUFA date in Dec’2020. In 2013, Pfizer & Eli Lilly collaborated to develop and commercialize tanezumab as non-opioid pain medication addressing the unmet medical needs of patients

Click here ­to­ read full press release/ article | Ref: Eli Lilly  | Image: GMP News