Rheumatoid Arthritis Drug on Hold After FDA Rejection

The FDA discovered deficiencies in a Sanofi manufacturing facility for the rheumatoid arthritis drug sarilumab.

Sanofi and Regeneron recently announced that they have received a complete response letter from the FDA rejecting the Biologics License Applications they submitted for the experimental rheumatoid arthritis drug sarilumab.

Sarilumab is an interleukein-6 receptor antibody for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA), according to a press release from Sanofi. The drug has been studied in multiple preclinical and clinical trials, including those studying the drug against traditional RA treatments.

"In this study, sarilumab monotherapy provided stronger efficacy than adalimumab monotherapy. Adalimumab is one of the most commonly used biologic medicines in RA," said Janet van Adelsberg, MD, Regeneron senior director, Clinical Sciences, Immunology and Inflammation in a previous press release. "This is the first time an IL-6 receptor blocker delivered subcutaneously has demonstrated superiority over adalimumab monotherapy in RA."

Sarilumab was studied in the phase 3 SARIL-RA program in August, and the FDA accepted the drug’s Biologics License Application for review with an action date of October 30, 2016, Regeneron reported in its second quarter results. They also submitted a Marketing Authorization Application to the European Medicines Agency, which was accepted.

The complete response letter refers to deficiencies discovered during a FDA investigation of good manufacturing practices of a Sanofi facility located in France. The syringes are filled with sarilumab at this facility, which is a last step in the manufacturing process.

Before the FDA can approve the biologic license application, these deficiencies need to be resolved. Sanofi has already submitted a comprehensive correction action plan, and is implementing the actions outlined in the plan, according to the press release.

They are also working closely with the FDA to resolve the deficiencies in a swift manner. Despite the deficiencies discovered in the facility, the letter does not disclose concerns about the safety or efficacy of the drug.

Both companies are committed to developing sarilumab as a treatment for patients with rheumatoid arthritis, and wish to make the drug available as soon as possible, Sanofi concluded.