FDA Approves Biogen and AbbVie's Once-Monthly MS Drug Zinbryta

May 31, 2016
By Alex Keown, BioSpace.com Breaking News Staff

CAMBRIDGE, Mass. – A once-per-month injection for multiple sclerosis developed by Biogen and Illinois-based AbbVie received approval from the U.S. Food and Drug Administration (FDA) on May 27.

Zinbryta was approved for the treatment of relapsing forms of multiple sclerosis. However, the drug comes with a boxed warning, the most serious warning label provided by the regulatory agency. The FDA recommends the drug be prescribed to patients who have had an “inadequate response to two or more MS drugs” due to safety concerns. The FDA said Zinbryta has serious safety risks, including liver injury and immune conditions. In addition to possible liver damage, the boxed warning highlights other risks of using Zinbryta, including inflammation of the colon (non-infectious colitis), skin reactions, and enlargement of lymph nodes (lymphadenopathy). Because of the risks, Zinbryta is restricted to prescribers, pharmacies and patients enrolled in the ZINBRYTA Risk Evaluation and Mitigation Strategy Program, which includes required monthly liver function tests.

The injectable, Zinbryta, is a long-acting injection that is self- administered by the patient monthly. Both Biogen and AbbVie will be co-marketing the drug in the United States.

“Zinbryta is the first once-monthly, self-administered treatment in MS, and it demonstrated superior efficacy over a widely used interferon. Clinical data showed Zinbryta significantly reduced relapses and brain lesions for up to three years compared to Avonex (interferon beta-1a) intramuscular injection, and has a positive benefit-risk profile with monthly patient monitoring,” Alfred Sandrock, Biogen’s chief medical officer, said in a statement.

While the precise mechanism of action of Zinbryta is unknown, Biogen and AbbVie said it is thought to work by binding to CD25, a subunit of the interleukin-2 (IL-2) receptor found on activated lymphocytes, cells believed to underlie the biology of MS. Total lymphocyte, T and B cell counts decreased less than 10 percent from baseline during the first year of treatment.

Multiple sclerosis is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. MS affects more than 2.3 million people worldwide. Relapsing MS is the most common form of the disease, accounting for 85 percent of cases, Biogen said.

Zinbryta was approved based on from two clinical trials, including Decide, the largest and longest head-to-head Phase III clinical trial ever conducted in multiple sclerosis. Some patients in the trial were treated for up to three years. During the trial, Zinbryta significantly reduced the annualized relapse rate (ARR), the primary endpoint of the studies, by 45 percent compared to Biogen’s Avonex for up to 144 weeks, AbbVie and Biogen said in a joint statement. Additionally, the study showed at up to 144 weeks on Zinbryta, 67 percent of patients were relapse free compared to 51 percent of the patients taking Avonex.

“MS patients are in need of therapeutic choices to help manage their disease and ZINBRYTA is an important new option for patients,” Michael Severino, AbbVie’s chief scientific officer, said in a statement. “AbbVie is committed to making a remarkable impact on the lives of patients, including in MS where there are particular unmet needs.”

Zinbryta is up for approval in Europe.