This article is more than 5 years old. Information may no longer be current.
Pfizer: FDA extends date for rheumatoid arthritis drug application
Click Here to Manage Email Alerts
The FDA has extended the action date for the New Drug Application for tofacitinib, a proposed rheumatoid arthritis drug from Pfizer, the company announced today in a press release.
Pfizer announced recently that the FDA had requested additional analysis of existing data on the Janus kinase 3-inhibitor. The FDA said the new information became a major amendment to Pfizer’s application and required additional review time. The FDA anticipates a Prescription Drug User Fee Act date of Nov. 21, according to the release.
“We believe that the results from the comprehensive multistudy clinical development program for tofacitinib have demonstrated a favorable benefit-risk profile, and we remain committed to working expeditiously with the FDA to make tofacitinib available to patients,” Yvonne Greenstreet, MD, senior vice president and head of the Medicines Development Group for Pfizer Specialty Care, said in the release.
The FDA Arthritis Advisory Committee voted 8-2 on May 9 in favor of tofacitinib as a treatment for patients with rheumatoid arthritis (RA).
If approved, tofacitinib would be the first new oral disease-modifying antirheumatic drug for RA in more than 10 years, Pfizer said.
The company said it is progressing with applications for tofacitinib in Europe and Japan.