The U.S. Food and Drug Administration on Friday approved a once-monthly injection for multiple sclerosis from Biogen Inc and AbbVie Inc, with a boxed warning. “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”. The black box cautions against “severe liver injury, including life-threatening and fatal events” associated with the med, the FDA said in a statement. 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.
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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.
Zinbryta’s efficacy in reducing annualized relapse rates was shown to be comparable, or slightly better, than standard-of-care Avonex in two late-stage studies. The second study compared daclizumab with placebo in 412 patients who were treated for 52 weeks.
Additional highlighted warnings include hypersensitivity reactions (anaphylaxis or angioedema), increased risk of infections, and symptoms of depression and/or suicidal ideation. “Zinbryta provides a meaningful new treatment option that demonstrates efficacy and offers once-monthly dosing”. In that study, those receiving Zinbryta had fewer relapses compared to those receiving placebo.
Zinbryta can also cause immune conditions such as non-infectious colitis, upper respiratory tract infection, lymphadenopathy, nasopharyngitis and skin reactions such as dermatitis, eczema and rashes.
While Zinbryta is proven to be effective, it has serious side effects.
Zinbryta is manufactured by Biogen, Inc. of Cambridge, Massachusetts.
There are also a number of newer oral meds for MS, including Novartis’ ($NVS) Gilenya as well as Biogen’s own Tecfidera and its every-two-weeks MS treatment in Plegridy.
The US Zinbryta prescribing information includes a boxed warning for a risk of hepatic injury and immune-mediated disorders.
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Both Biogen and AbbVie will be co-marketing the drug in the United States. Relapsing MS is the most common form of the disease, accounting for 85 percent of cases, and is characterized by clearly defined acute attacks with full recovery or with residual deficit upon recovery. Most people experience their first symptoms of MS between the ages of 20 and 40.
