Zinbryta (daclizumab) was approved May 27 for the treatment of adults with relapsing multiple sclerosis (MS). The U.S. Food and Drug Administration (FDA) cleared Biogen’s new long-acting injection as a patient self-administered monthly therapy.
The director of Neurology Products at the U.S. FDA’s Center for Drug Evaluation and Research, Dr. Billy Dunn said in a press release: “Zinbryta provides an additional choice to patients who may require a new option for treatment.”
Zinbryta is indicated for use by patients who have had an inadequate response to at least two other MS drugs, but it is associated with serious safety risks – including liver injury or immune malignancies, like non-infectious colitis, skin reactions and enlargement of lymph nodes (lymphadenopathy).
Because of the risks, Biogen issued a boxed warning for Zinbryta, which is available only through a restricted distribution program under a ‘Risk Evaluation and Mitigation Strategy’. Possible leading side effects are liver injury and immune system conditions.
The company advises healthcare professionals to perform blood tests to monitor patient liver function before starting treatment with Zinbryta, and then monthly before each dose for up to six months after the last dose of treatment.
Zinbryta’s effectiveness was demonstrated in two clinical trials: one comparing Zinbryta and Avonex (interferon beta-1a injection) in 1,841 participants for 144 weeks, in which patients receiving Zinbryta were found to have fewer clinical relapses than patients under Avonex therapy. The second trial compared Zinbryta with placebo in 412 participants for 52 weeks, and showed that patients receiving Zinbryta had fewer relapses.
The most common adverse reactions reported by patients in the Zinbryta vs. Avonex trial included cold symptoms (nasopharyngitis), upper respiratory tract infection, throat (oropharyngeal) pain, eczema, and enlargement of lymph nodes. In the Zinbryta vs. placebo trial, the most commonly reported adverse reactions included depression, rash, and increased levels of alanine aminotransferase.
Additional highlighted warnings for Zinbryta therapy include hypersensitivity reactions, such as anaphylaxis or angioedema; increased risk of infections; and depression or suicide thoughts.
MS is a chronic, inflammatory, autoimmune disease that damages the central nervous system (CNS) and disrupts communication between the brain and other parts of the body. The neurologic disability causes episodes of worsening function (relapses) which are followed by periods of remission that become less and less effective over time.