FDA Approves First Injectable for Relapsing and Progressive MS

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The FDA has approved a new injectable form of the multiple sclerosis drug ocrelizumab for use in adults with relapsing and progressive forms of the disease.

Multiple sclerosis occurs when the body's immune system mistakenly attacks the protective covering of the nerves in the brain and spinal cord. The new FDA-approved drug combines ocrelizumab with hyaluronidase, an enzyme that breaks down substances in the body. While ocrelizumab slows the immune attack, hyaluronidase makes it easier for the drug to be absorbed when injected under the skin. This treatment will need to be given twice a year, with the drug requiring about 10 minutes to be injected, the drug's manufacturer said.

Genentech, the drug's manufacturer, said in a press release that clinical trials showed that the drug, to be marketed under the brand name Ocrevus Zunovo, achieves comparable levels of ocrelizumab in the blood when given subcutaneously. The treatment is as safe and effective as the standard intravenous treatment, the company said.

This new treatment may offer "greater flexibility for healthcare providers and people living with multiple sclerosis, based on their individual treatment needs," said Levi Garraway, MD, PhD, Genentech's chief medical officer and head of global product development.