FDA demands more data on Novartis's ACZ885

Novartis's ($NVS) plans to expand the use of ACZ885 in a drive to achieve blockbuster status ran into a roadblock this morning. The pharma giant says that the FDA handed the company a complete response letter detailing its demands for more data on gouty arthritis patients ahead of any final decision on the treatment. The FDA wants more data on the clinical risk/benefit in refractory patients. An expert panel voted in favor of the drug's efficacy back in June but noted the need for more safety data. Report

Suggested Articles

The FDA accepted the regulatory filing for Biogen's once-failed Alzheimer's drug, aducanumab, with plans to decide its fate by March 7, 2021.

Alexion named a chief diversity officer, while COVID-19 vaccine player has two new members of its C-suite.

Scientists at Sanford Burnham Prebys suggested that inhibiting the PPP1R1B protein could be a new strategy for treating pancreatic cancer.