The EC approved the drug for adults and adolescents (12 years of age or older with a weight of 40 kg and above) suffering from PNH who are either new to or have been previously treated with C5 ...

Primary support for the approval of crovalimab came from COMMODORE 2, a phase III noninferiority study that randomized 204 PNH patients 2:1 to either crovalimab or the C5 inhibitor eculizumab ...

Additional competition in PNH will come from Novartis’ recently approved oral therapy Fabhalta (iptacopan), a targeted factor B inhibitor that in trials was shown to be more effective than ...

PNH was once a rare disease with no approved therapeutic options. The market for PNH drugs is now growing crowded. Soliris’s 2007 approval made it the first therapy for the disorder.

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 ...

Following achievements in Asia, Roche's PNH treatment drug PIASKY (crovalimab) received its first FDA approval. This approval has spiked the competition between Roche and current market leader ...

Novartis said it would report full data from APPLY-PNH at a future medical meeting and plans to file for approval of the drug for PNH in 2023.

Three new drugs have been approved to treat anaemic patients suffering from Paroxysmal nocturnal haemoglobinuria, estimated to impact 1.59 people per 100,000 in the UK, with 38 patients treated in ...

Roche RHHBY announced that the European Commission (EC) approved PiaSky (crovalimab) for treating patients suffering from paroxysmal nocturnal hemoglobinuria (PNH). PiaSky is a novel recycling ...

Paroxysmal nocturnal hemoglobinuria (PNH), a rare disorder, ... The drug was approved in March 2024 and launched in May 2024 for patients with PNH aged 12 years and above.

PR Newswire LAS VEGAS, Sept. 2, 2024 Following achievements in Asia, Roche's PNH treatment drug PIASKY (crovalimab) received its first FDA approval.