FDA Approves Dalizumab

June 2, 2016
BioPharm International Editors

FDA approved dalizumab a monoclonal antibody for the treatment of multiple sclerosis.

On May 27, 2016 FDA approved Zinbryta (dalizumab), a monoclonal antibody (mAb) for the treatment of adults with relapsing forms of multiple sclerosis (MS), the agency said in a press announcement. FDA initially approved dalizumab in 1997 to prevent organ rejection after transplant, under the name Zenapax. Zinbryta was co-developed by Biogen and AbbVie and joins Roche’s ocrelizumab as another mAb treatment for multiple sclerosis.

Zinbryta is a long-acting injection, which can be self administered on a monthly basis by the patient. FDA advises the drug be used only in patients who have had an inadequate response to two or more MS drugs, as the drug has some serious safety risks. The drug contains a boxed warning, which informs prescribers that it may cause liver injury, inflammation of the colon, skin reactions, enlargement of the lymph nodes, hypersensitivity reactions, increased risk of infection, and symptoms of depression and/or suicide ideation. FDA says health professionals should monitor patients liver function prior to starting Zinbryta, monthly before each dose, and up to six months after the last dose.

In clinical trials, Zinbryta was compared to Biogen’s Avonex (interferon beta-1a), and patients taking Zinbryta showed fewer clinical relapses than patients taking Avonex. In another trial, the Zinbryta was compared to a placebo, and patients taking the drug had fewer relapses than those taking the placebo. 

Source: FDA