Is Ocrevus FDA Approved for Relapsing MS?

**Ocrevus is FDA-approved for the treatment of relapsing forms of multiple sclerosis (MS).** This includes clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS) in adults. It is also approved for primary progressive MS (PPMS), which is a form of MS characterized by steady worsening of symptoms from the onset without relapses[1][3][5].

Ocrevus (generic name: ocrelizumab) is a targeted therapy that works by selectively binding to a protein called CD20 found on the surface of B-lymphocytes, a type of white blood cell involved in the immune response. By binding to CD20, Ocrevus causes these B-cells to self-destruct, which helps reduce the abnormal immune activity that damages the nervous system in MS[1].

The approval of Ocrevus for relapsing MS was based on clinical trials demonstrating its effectiveness in reducing the frequency of relapses, increasing the proportion of patients who remain relapse-free, and slowing the progression of disability. For example, patients treated with Ocrevus showed fewer relapses per year compared to those on placebo or other treatments. It also showed benefits in delaying disability progression, which is a critical goal in managing MS[1][3].

Ocrevus is administered via infusion, typically given every six months after an initial dosing schedule of two infusions two weeks apart. There are two formulations: the original intravenous infusion and a newer subcutaneous injection form called Ocrevus Zunovo. Both forms are used under medical supervision, with the subcutaneous form injected into the abdomen by healthcare professionals[2][6].

The treatment is generally well-tolerated, but like all medications, it can cause side effects. Common side effects include respiratory infections and injection site reactions. More serious but less common risks include infections caused by herpes viruses and other opportunistic infections. Patients are screened for hepatitis B before starting treatment because Ocrevus can reactivate this virus in some cases[2][4].

Cost can be a consideration, as Ocrevus is an expensive medication. However, many patients with commercial insurance, Medicare, or Medicaid may have access to co-pay assistance programs or financial aid to reduce out-of-pocket expenses[1].

In summary, Ocrevus is a significant FDA-approved treatment option for adults with relapsing forms of MS, offering a targeted approach to reduce disease activity and slow progression with a convenient dosing schedule. Its approval reflects strong clinical evidence supporting its efficacy and safety in managing this chronic neurological condition.