Genentech applies for FDA approval of new Actemra specification

Genentech is applying for Food and Drug Administration (FDA) approval of a new specification for its monoclonal antibody treatment Actemra.

The Roche subsidiary has submitted a supplemental biologics licence application for the drug to be used for preventing structural joint damage among sufferers of rheumatoid arthritis.

This application is based on positive results from phase III clinical trials, which demonstrated its efficacy for this purpose when used in combination with methotrexate.

Currently, the treatment is approved by the FDA for treating rheumatoid arthritis patients who have proven unresponsive to tumour necrosis factor antagonist medications.

Dr Hal Barron, head of global development and chief medical officer at Roche, said: “Actemra inhibits the progression of the disease by reducing long-term joint damage and improves physical functions, which are important goals of treating this chronic, debilitating disease.”

Genentech recently submitted an application to the FDA for approval of a new cancer drug developed in collaboration with Seattle Genetics, with Genentech paying a milestone imbursement as a result.