Pfizer will discontinue its development program for bococizumab, a proprotein convertase subtilisin kexin type 9 inhibitor (PCSK9i) that works by blocking the function of the PCSK9 protein, which interferes with the clearance of low-density lipoprotein cholesterol (LDL-C).
According to the company, “bococizumab is not likely to provide value to patients, physicians, or shareholders.” Two ongoing cardiovascular outcome studies will be halted.
“As a company, we understand that developing new and important medicines for patients is a critical, but difficult undertaking. Accordingly, we continually evaluate our development programs as data emerge to support prudent decisions that provide value both to the patients we serve and our shareholders,” said James Rusnak, M.D., Ph.D., chief development officer, cardiovascular and metabolic diseases, Pfizer Global Product Development. “We are disappointed by this outcome, but remain committed to investing in innovation, concentrating our pipeline on areas where we can bring transformational therapies to address unmet needs, including in patients with cardiovascular and metabolic diseases.”
Pfizer has committed to ensuring that the data will be made available for independent analysis and public presentation. “We believe the available data will allow us to test the core scientific questions posed by the overall program which is in the best interest of patients who volunteered in these clinical trials, and for patients worldwide who suffer from heart disease,” stated Paul M. Ridker, M.D., co-chair executive committee, SPIRE clinical trials program and director for Cardiovascular Disease Prevention, Brigham and Women’s Hospital.