UK's NICE calls for more data to consider Roche drug for a type of vasculitis

UK drug watchdog the National Institute for Health and Care Excellence (NICE) has today (July 23) published draft guidance on Swiss drug major Roche’s (ROG: SOX) blockbuster cancer drug MabThera (rituximab), which is also licensed for inducing remission in adults with a type of vasculitis (inflammation of the blood vessels) called anti-neutrophil cytoplasmic antibody [ANCA]-associated vasculitis (severely active granulomatosis with polyangiitis [GPA] and microscopic polyangiitis).

The NICE says it is minded not to recommend rituximab in combination with glucocorticoids as an option for this patient group, and asks for further information from the manufacturer for consideration at the next Committee meeting.

ANCA-associated vasculitis is an inflammatory autoimmune disease affecting blood vessel walls. It can affect many organs and leads to tissue breakdown and damage. GPA and microscopic polyangiitis are both types of ANCA-associated vasculitis that affect small blood vessels. ANCA-associated vasculitis usually affects the lungs, kidneys, ears, nose or sinuses. Depending on the organs involved it can cause bleeding, rash, or deafness. It is estimated that around 1200 people are diagnosed with ANCA-associated vasculitis each year in England and Wales and it is most common in those aged between 60 and 70 years.