FDA approves first monthly self-administered MS injection despite side effects

The Food and Drug Administration (FDA) has approved Zinbryta (daclizumab), a once-monthly injection for treating relapsing multiple sclerosis (MS) that patients can administer themselves.

The agency has attached a boxed warning to the medication, however, because of some serious safety concerns, and also recommended it only be used by patients who haven’t had success with two or more MS treatments.

The drug was shown to be effective in two separate clinical trials, according to the FDA, with Zinbryta patients experiencing fewer MS relapses and brain lesions compared to those on Avonex or a placebo.

“MS patients are in need of therapeutic choices to help manage their disease, and Zinbryta is an important new option for patients," Michael Severino, MD, executive vice president, research and development and chief scientific officer, AbbVie, said in a statement. AbbVie is one of the creators of the drug along with Biogen.

The risks involved in using the medication include severe liver injury, non-infectious colitis, upper respiratory tract infection, skin reactions and enlargement of the lymph nodes. Depression and suicidal ideation were also noted in Zinbryta patients.

Because of the potential liver damage, the FDA said physicians should perform blood tests to monitor a patient’s liver function prior to starting Zinbryta, after each monthly dose and for up to six months after the last dose.