China has become the first country to sign off on Roche’s paroxysmal nocturnal hemoglobinuria (PNH) drug crovalimab, a subcutaneous answer to AstraZeneca’s infused treatments Soliris and Ultomiris.
Roche’s subsidiary Chugai Pharmaceutical, which developed crovalimab and owns its rights in Japan and Taiwan, announced the approval of the humanized complement inhibitor C5 monoclonal antibody. China’s National Medical Products Administration (NMPA) will permit its use in patients age 12 and older who have not received complement inhibitor therapy.
The nod comes 12 months after Roche presented results of a phase 2 study that showed crovalimab measured up to Soliris, a blockbuster developed by AZ subsidiary Alexion, which has dominated the PNH market for more than a decade. Roche has conducted three successful phase 3 trials, including COMMODORE 3 in China, which paved the way for the NMPA approval.
Crovalimab is the second approved drug developed with Chugai’s recycling antibody technology. The other is Enspryng for the treatment of neuromyelitis spectrum disorder (NMOSD), which was cleared by the U.S. FDA in 2020.
While antibodies typically bind to an antigen only once, crovalimab is designed to bind to the antigen repeatedly, enabling sustained complement inhibition at a low dose. This allows the treatment to be administered every four weeks, the company explained.
Another advantage of crovalimab is that it can be self-administered. It presents an alternative to Soliris and Utomiris, which are infused every two and eight weeks, respectively.
The PNH market is significant. This morning, AstraZeneca reported 2023 sales of Soliris, which was approved by the FDA in 2007, at $3.2 billion. Longer-acting Ultomiris, which was approved in 2021, generated $3 billion last year. Both drugs also are approved to treat generalized myasthenia gravis (gMG) and atypical hemolytic uremic syndrome (aHUS).
Another PNH competitor emerged in 2021 when Apellis scored a green light for Empaveli. Two months ago, Novartis gained an FDA blessing for Fabhalta, an oral alternative which may have an advantage over AstraZeneca’s products as it works upstream of the C5 terminal pathway.
Elsewhere, Roche has submitted for approval of crovalimab in the U.S., Europe and Japan.