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Phase III Success For Roche’s Crovalimab In Crowded PNH Market

But AstraZeneca Expected To Retain Grip In The Space

 
• By Andrew McConaghie

Roche is looking to challenge AstraZeneca's dominance in PNH with its subcutaneously administered once-a-month treatment but could struggle to rival the company's and Novartis’s oral therapy.

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Roche expects to file crovalimab shortly and expects a US FDA approval by late 2023/ early 2024.

Roche has unveiled positive topline results from a non-inferiority study in paroxysmal nocturnal hemoglobinuria (PNH) between crovalimab and AstraZeneca’s blockbuster incumbent, Soliris (eculizumab).

AstraZeneca’s rare disease division Alexion has dominated the PNH market for years and its anti-C5 monoclonal antibodies Soliris and Ultomiris (ravulizumab) are set to chalk up 2022

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