MabThera (rituximab) is the first drug to be licensed for treatment of GPA and MPA – two auto-immune disorders that cause inflammation of small blood vessels, often leading to organ failure.
Used in combination with glucocorticoids, MabThera can achieve remission in patients with severe, active GPA or MPA.
One of Roche’s most successful biopharmaceuticals, MabThera is a monoclonal antibody that selectively targets the CD20 surface marker on certain B cells.
GPA and MPA affect over 13,000 people in the UK; both diseases usually arise in patients aged over 60, and are usually fatal if not treated.
The license is based on clinical trial data that showed MabThera induced complete remission at six months in 64% of patients, compared to 53% of patients treated with cyclophosphamide.
“This licence is much-welcomed news for patients suffering from these rare diseases,” said Dr David Jayne, Consultant in Nephrology and Vasculitis at Addenbrookes Hospital, Cambridge. “GPA and MPA can strike suddenly and have a serious impact on a person’s life and overall health, with the likelihood of relapse high.
“MabThera, as the first and only licensed treatment for these debilitating conditions, not only means that more patients will have an additional treatment option, but will also have a chance of achieving remission or getting back into remission when their disease has relapsed.”