SMC Approves Roche’s MabThera

Scottish regulatory body, the Scottish Medicines Consortium (SMC), have approved Roche’s MabThera (rituximab) for the National Health Service (NHS) in Scotland.

MabThera has been approved to treat two potentially life-threatening illnesses, GPA and MPA.

The decision will provide patients with access to the first licensed medicine for these autoimmune diseases, which presently are treated off-label with chemotherapy drugs.

Roughly 13,000 patients in the UK are affected by GPA (active granulomatosis with polyangiitis) or MPA (microscopic polyangiitis), which if left untreated, can cause the blood vessels to become inflamed and die, potentially leading to organ failure and death.

According to Roche, treatment with MabThera provided effective induction of complete remission at six months in 64% of patients, in comparison to 53% with current standard of care cyclophosphamide.

The regulatory agency have agreed that the drug is both clinically and cost effective, but has restricted use of MabThera to patients who have either relapsed following treatment with cyclophosphamide or who are intolerant to/unable to receive cyclophosphamide.


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