Roche announced that the Swiss agency for the authorisation and supervision of therapeutic products (Swissmedic) has granted authorisation of Ocrevus (ocrelizumab) for the treatment of adult patients with active relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). MS, which affects almost 15,000 people in Switzerland, is the leading cause of non-traumatic disability in young adults and often results in serious and permanent disabilities.

“The approval of Ocrevus in Switzerland, the first in Europe, is a significant moment for the Swiss MS community, and we are pleased that the regulators have recognised how the clinically meaningful results for Ocrevus may benefit people with active relapsing forms of MS and primary progressive MS,” said Sandra Horning, MD, Roche’s chief medical officer and head of global product development. “Despite available therapies, some people with relapsing forms of MS continue to experience disease activity and disability progression, and people with primary progressive MS, who have never had an approved treatment, experience a faster accumulation of disability. Ocrevus, given every six months, has the potential to transform the treatment of both relapsing forms of MS and primary progressive MS.”

Ocrevus is the first medicine to be approved in Switzerland for PPMS, which affects approximately 15 per cent of people with MS. PPMS is a debilitating form of the disease marked by steadily worsening symptoms, but typically without distinct relapses or periods of remission. Additionally, disability accumulates twice as fast in PPMS as in RMS, meaning that people with PPMS may have to rely on mobility aids or become wheelchair bound, are unable to work, and need carers to look after them sooner. In contrast, RMS, the most common form, is characterised by episodes of new or worsening signs or symptoms (relapses) followed by periods of complete or incomplete recovery.

“The approval of Ocrevus for both active relapsing forms of MS and primary progressive MS in Switzerland is much welcomed news for people with one of these two forms of MS that can radically alter the lives of those affected and their families,” said Professor Ludwig Kappos, Head Physician of the Department of Neurology and Outpatient Clinic at the University Hospital of Basel. “Ocrevus offers people with active relapsing forms of MS a treatment with a favourable benefit/risk profile and is the first medicine demonstrating efficacy and delaying the progression of disability in people with primary progressive MS.”

In the Phase III ORATORIO study for PPMS, Ocrevus significantly slowed disability progression and reduced signs of disease activity in the brain (MRI lesions) compared with placebo. In the Phase III OPERA I and OPERA II studies for RMS, Ocrevus demonstrated superior efficacy on the three major markers of disease activity, slowing the worsening of disability and significantly reducing MRI lesions compared with Rebif® (high-dose interferon beta-1a). The most common side effects associated with Ocrevus in all Phase III studies were infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity.

Ocrevus has been approved for use in countries across North America, South America, the Middle East, Eastern Europe, and in Australia. Marketing applications for Ocrevus are currently under review in over 50 countries across the world.
About Ocrevus (ocrelizumab)

Ocrevus is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with multiple sclerosis (MS). Based on preclinical studies, Ocrevus binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.

Ocrevus is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.
About the OPERA I and OPERA II studies in relapsing forms of MS

OPERA I and OPERA II are phase III, randomised, double-blind, double-dummy, global multi-centre studies evaluating the efficacy and safety of Ocrevus (600 mg administered by intravenous infusion every six months) compared with interferon beta-1a (44 mcg administered by subcutaneous injection three times per week) in 1,656 people with relapsing forms of MS. In these studies, relapsing MS (RMS) was defined as relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS) with relapses. A similar proportion of patients in the Ocrevus group experienced serious adverse events and serious infections compared with patients in the high-dose interferon beta-1a group in the RMS studies.

ORATORIO is a phase III, randomised, double-blind, global multi-centre study evaluating the efficacy and safety of Ocrevus (600 mg administered by intravenous infusion every six months; given as two 300 mg infusions two weeks apart) compared with placebo in 732 people with primary progressive MS (PPMS). The blinded treatment period of the ORATORIO study continued until all patients had received at least 120 weeks of either Ocrevus or placebo and a predefined number of confirmed disability progression (CDP) events was reached overall in the study. A similar proportion of patients in the Ocrevus group experienced adverse events and serious adverse events compared with patients in the placebo group in the PPMS study.