JasonDoiy
- The U.S. has granted approval to Roche (OTCQX:RHHBY)-owned Genentech’s biologic crovalimab to treat the rare condition paroxysmal nocturnal hemoglobinuria.
- The application was supported by two phase 3 trials, one of which demonstrated that crovalimab achieved disease control and was well-tolerated while the other showed a consistent benefit-risk for the monoclonal antibody.
- Crovalimab, which will be marketed under the name Piasky, is seen as a competitor to AstraZeneca’s Soliris (eculizumab). However, while Soliris is dosed every two weeks, Piasky is given monthly.
- AstraZeneca also markets Ultomiris (ravulizumab) for PNH. While Ultomiris can be given via infusion every other month, Piasky’s ability to be dosed via subcutaneous injection monthly that can be done by a patient at home is seen as an advantage.
- PNH is a rare disorder in which certain red blood cells break apart prematurely. The defective red blood cells are destroyed by part of the body’s own immune system called the complement system. This can lead to anemia, fatigue, blood clots and kidney disease, according to Genentech.