Artificial intelligence to speed diagnosis, switching complement therapies, ravulizumab during pregnancy, and iptacopan ...

AJMC ®: How has treatment of complement-driven diseases changed since 2007, when the first complement inhibitor, eculizumab, was approved? SMITH: The development of eculizumab followed our ...

"We need longer follow-up with the newer complement inhibitors to be sure that they’re safe long-term and that there won’t be excessive intravascular breakthrough hemolysis/thrombosis. Some of these ...

– If approved, crovalimab will be the first monthly subcutaneous treatment for PNH, with the option to self-administer outside of a supervised healthcare setting – “This filing acceptance reinforces ...

– The COMMODORE 2 study demonstrated that subcutaneous crovalimab every four weeks was non-inferior to intravenous eculizumab every two weeks, with comparable safety, in people new to C5 inhibitors – ...

Cedric Francois, MD, PhD, Apellis Pharmaceuticals co-founder and CEO/President With its first FDA approval in hand for a complement inhibitor designed to treat paroxysmal nocturnal hemoglobinuria (PNH ...

A recent study found that thrombotic events occurred in 3 out of 26 patients who received eculizumab, compared with 3 out of 13 who did not receive the therapy. Some symptoms, including abdominal ...

Roche Group RHHBY member Genentech has received a significant boost following the acceptance of its biologics license application (BLA) for pipeline candidate crovalimab by the FDA. Crovalimab, an ...

Credit: Novartis. The approval was based on data from the phase 3 APPLY-PNH trial. Health care providers who prescribe Fabhalta must enroll in the Fabhalta REMS. The Food and Drug Administration (FDA) ...

For years, Alexion has been the only name in the game for a blood disease called paroxysmal nocturnal hemoglobinuria (PNH). Now, a number of Big Pharmas want in, vying to show their candidates can go ...