European Commission approves Roche's MabThera (rituximab) for a rare autoimmune disease

F. Hoffmann-La Roche Ltd / European Commission approves Roche's MabThera (rituximab) for a rare autoimmune disease . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• MabThera is the first biologic treatment approved for moderate to severe cases of the rare autoimmune disease pemphigus vulgaris (PV), and the first major advancement in the treatment of the disease in more than 60 years

PV is a rare and potentially life-threatening blistering condition which can cause severe pain and disfigurement

MabThera is now approved in Europe to treat four autoimmune diseases

Basel, 15 March 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved MabThera (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare condition characterised by progressive painful blistering of the skin and/or mucous membranes.^[1] Extensive blistering can lead to serious, life-threatening fluid loss, infection and/or death.^[2]

MabThera is the first biologic therapy approved by the European Commission for PV and the first major advancement in the treatment of the disease in more than 60 years. Following approval by the US Food and Drug Administration (FDA) in June 2018 and today's decision, MabThera is now approved to treat four autoimmune diseases in the US and Europe.

"We're pleased to bring the first biologic medicine to the more than 50,000 people in Europe suffering from pemphigus vulgaris," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "This MabThera approval provides a much needed new treatment that has been shown to provide higher remission rates than corticosteroids alone, which can cause debilitating side effects."

The European approval is based on data from the phase III Ritux 3 trial, a Roche-supported randomised controlled study, conducted in France, which evaluated MabThera plus a tapering regimen of oral corticosteroids (CS) compared to a standard dose of CS alone, as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus. The primary endpoint of the study was complete remission at month 24 without the use of CS for two or more months. The study demonstrated that 89.5% of people with PV treated with MabThera, in combination with short-term oral CS treatment, achieved complete remission without the use of CS for two or more months, compared to 27.8% of people with PV receiving CS alone, the current standard of care.^[3] The results of the Ritux 3 trial were published in The Lancet in March 2017.^[4]