dm+d

Unassigned

New Medicines

Intermittent treatment of generalised myasthenia gravis (gMG) patients that have moderate to severe symptoms and are inadequately controlled on current therapy

Information

New molecular entity
UCB Pharma
UCB Pharma

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes

Category

Rozanolixizumab blocks FcRn-IgG interactions so inhibiting IgG recycling and inducing removal of pathogenic IgG autoantibodies.
The incidence ranges from 0.3 to 2.8 per 100,000. It is estimated to affect more than 700,000 people worldwide. The prevalence of MG in the UK is estimated at about 15 per 100,000 population [1].
Intermittent treatment of generalised myasthenia gravis (gMG) patients that have moderate to severe symptoms and are inadequately controlled on current therapy
Subcutaneous injection

Primary immune thrombocytopenia (ITP)

Information

Licence extension / variation
UCB Pharm
UCB Pharm

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Rozanolixizumab blocks FcRn-IgG interactions so inhibiting IgG recycling and inducing removal of pathogenic IgG autoantibodies.
Adult incidence is about 3.3 per 100,000 and UK 18-year prevalance about 50 per 100,000, from 2010 and 2011 studies respectively; childhood incidence is about 2.2-5.3 per 100,000 children per year [2]. NICE estimates that UK incidence is about 120 per year and prevalence in England and Wales at any one time is 3,000 to 3,500 [5].
Primary immune thrombocytopenia (ITP)
Intravenous infusion