Roche’s MabThera receives NICE approval for vasculitis

Roche has announced that its drug MabThera has been approved by the UK's National Institute for Health and Care Excellence (NICE) for the treatment of two potentially life-threatening autoimmune diseases.

The drug has become the first and only licensed treatment for severe forms of Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), forms of vasculitis that can lead to the inflammation and damage of small blood vessels and frequently involve multiple organs.

It is licensed in combination with glucocorticoids for the treatment of severe and active GPA or MPA, based on positive clinical trial data showing the safety and efficacy of the drug in these indications.

MabThera has an established safety profile across a number of disease areas, as demonstrated in over 3.5 million patient exposures spanning 14,000 patient years.

Dr David Jayne, consultant in nephrology and vasculitis at Addenbrookes Hospital, said: "The availability of MabThera for patients in England and Wales provides us with great hope for the future management of these diseases."

This comes in the same week that Europe's Committee for Medicinal Products for Human Use recommended regulatory approval of a subcutaneous version of MabThera for the treatment of patients with common forms of non-Hodgkin lymphoma.