Biotech Values

[DewDiligence]

PFE/LLY—FDA_adcomm_for Tanezumab_in_OA—scheduled_for 3/24-25/21:

https://www.fda.gov/advisory-committees/arthritis-advisory-committee/march-24-25-2021-joint-meeting-arthritis-advisory-committee-and-drug-safety-and-risk-management

The PDUFA date was in Dec 2020 (https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_accepts_regulatory_submission_for_tanezumab_a_potential_first_in_class_treatment_for_patients_with_chronic_pain_due_to_moderate_to_severe_osteoarthritis ), but the FDA was apparently unable to schedule the adcomm until recently.

This BLA will be controversial given the safety problems encountered at various stages of development program, which dates back to 2009! The problems have been thought to derive from the drug’s working too well at relieving OA pain, encouraging users to become more active and thereby causing more serious joint damage.