dm+d

Unassigned

New Medicines

Generalised myasthenia gravis (gMG) in adults with a documented history of acetylcholine receptor (AChR) or muscle-specific tyrosine kinase (MuSK) autoantibodies who require therapy in addition to corticosteroids and/or immunosuppressants

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].
Generalised myasthenia gravis (gMG) in adults with a documented history of acetylcholine receptor (AChR) or muscle-specific tyrosine kinase (MuSK) autoantibodies who require therapy in addition to corticosteroids and/or immunosuppressants
Subcutaneous injection

Further information

Yes

Evidence based evaluations

Primary immune thrombocytopenia (ITP)

Information

Licence extension / variation
UCB Pharma
UCB Pharma

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

Myelin oligodendrocyte glycoprotein antibody associated disease

Information

Licence extension / variation
UCB Pharma
UCB Pharma

Development and Regulatory status

None
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.
Myelin oligodendrocyte glycoprotein (MOG)-associated disease (MOGAD) is a rare, antibody-mediated inflammatory demyelinating disorder of the central nervous system (CNS) with various phenotypes starting from optic neuritis, via transverse myelitis to acute demyelinating encephalomyelitis (ADEM) and cortical encephalitis. MOGAD is a relatively new condition with low prevalence [1]. The exact incidence and prevalence of MOGASD is not known [2].
Myelin oligodendrocyte glycoprotein antibody associated disease
Subcutaneous infusion