The complement C5 inhibitor Ultomiris (ravulizumab) from AstraZeneca (LON:AZN) has won approval in Europe as adjunctive therapy for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
The regulatory nod represents the first approval for a long-acting C5 complement inhibitor for treating gMG in Europe.
While myasthenia gravis is a chronic autoimmune, neuromuscular disease associated with weakness of skeletal muscles, in gMG, the weakness extends to ocular muscles along with limb and respiratory muscles.
The onset of gMG is often age-related, frequently beginning in women before 40 and for men after 60.
There are approximately 89,000 patients in Europe with gMG.
AZN shares ticked up 0.55% to £9,989.00.
In July, the Committee for Medicinal Products for Human Use (CHMP) recommended approval of the drug for gMG. CHMP based its decision on data from the Phase 3 CHAMPI…