FDA approves Ocrevus to treat MS

The FDA approved Ocrevus, the first treatment for both relapsing and primary progressive forms of multiple sclerosis, according to a press release. It is the first drug approved for primary progressive MS.

“Multiple sclerosis can have a profound impact on a person’s life,” Billy Dunn, MD, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS.”

According to the CDC, roughly 15% of patients with MS have primary progressive MS, which is characterized by steadily worsening function from the onset of symptoms without the early relapses or remissions common in regular MS patients.

In two identical phase 3 trials of 1,656 participants treated for 96 weeks, Ocrevus (ocrelizumab, Genentech) showed superior efficacy for the treatment of relapsing forms of MS compared with another MS drug, Rebif (interferon beta-1a, Serono Inc.). Ocrelizumab reduced relapses per year by nearly half, slowing the worsening of disability over the 2-year treatment period.

A separate primary progressive MS phase 3 study found that those who received ocrelizumab experienced significantly slowed disability progression and reduced signs of disease activity in the brain compared with placebo during a median follow-up period of 120 weeks.

Ocrelizumab will be available within 2 weeks to people in the United States.

Ocrelizumab is an IV infusion given by a health care professional and dispensed with a patient Medication Guide that describes necessary information about the drug’s uses and risks. Common adverse events associated with ocrelizumab include infusion-related reactions and upper respiratory infections. Patients with hepatitis B virus infection or a history of life-threatening infusion-related reactions should not use ocrelizumab. The drug can increase risk for malignancies, particularly breast cancer.

Disclosure: Dunn reports no relevant financial disclosures.