10. Zinbryta

Syringe

Active ingredient: daclizumab
Disease: multiple sclerosis
Peak sales estimate: $500 million
Approved: May 27
Company: Biogen/AbbVie

The Scoop: With this approval, multiple sclerosis patients gained access to a novel mechanism of action in a once-monthly, self-administered subcutaneous injection. But the eventual market is expected to be limited given that the approval is only in relapsing MSand the fact that it was approved with a boxed warning on safety risks such as liver injury and immune conditions. The latter requires distribution of Zinbryta under a Risk Evaluation and Mitigation Strategy (REMS). Given these limitations, it’s going to be tough for Zinbryta to effectively shore up Biogen’s ailing MS franchise. The drug is a new form of a humanized monoclonal antibody that selectively binds to the high-affinity interleukin-2 receptor subunit (CD25), which is expressed at high levels on T cells that become activated in people with MS. -- Stacy Lawrence

10. Zinbryta
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