Roche announced positive results from its global phase 3 study evaluating the efficacy and safety of crovalimab in people with the rare blood disorder, paroxysmal nocturnal haemoglobinuria (PNH).
PNH occurs when part of your immune system attacks and damages your red blood cells and platelets. The current standard of care is AstraZeneca’s Soliris (eculizumab), which is given intravenously every two weeks.
But, according to Roche, results from the COMMODORE 2 study showed that crovalimab, a novel, investigational anti-C5 recycling monoclonal antibody given as a subcutaneous injection every four weeks, achieved disease control and was non-inferior to Soliris. Importantly, Roche's investigational mAb could potentially provide patients with an at-home administration option.
Soliris, the $3 billion show-stopper that AstraZeneca picked up in its $39 billion buy out of Alexion Pharmaceuticals in 2020, was first approved for PNH in 2007.
Roche says it intends to submit data from its two studies — COMMODORE 2 and a separate phase 3 COMMODORE 1 study in people with PNH switching from currently approved C5 inhibitors to crovalimab — to regulatory authorities around the world.
