Crovalimab

Unassigned

New Medicines

Paroxysmal nocturnal haemoglobinuria (PNH) in patients currently treated with complement inhibitors

Information

New molecular entity
Roche
Roche

Development and Regulatory status

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

Category

A humanised monoclonal antibody against complement C5, given with an IV loading dose followed by SC injections (schedule to be decided)
PNH is a very rare acquired bone marrow disorder characterised by intravascular haemolysis, with resultant anaemia; before effective treatments were available, median survival was 10 years from diagnosis and half of those affected died from complications. Spontaneous recovery may occur, but only in a minority of patients. [2] UK incidence is about 0.13/100,000/year and 15-year prevalence is likely to be around 1.59/100,000 [3].
Paroxysmal nocturnal haemoglobinuria (PNH) in patients currently treated with complement inhibitors
Intravenous infusion and
Subcutaneous injection