Chugai Pharmaceutical has submitted a new drug application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for crovalimab to treat paroxysmal nocturnal haemoglobinuria (PNH), a rare blood disorder in which parts of the immune system attack and damage red blood cells and platelets.

Crovalimab is an anti-C5 recycling antibody. C5 is an important component of the complement system [a system of plasma proteins] and the drug is expected to control its activity.

Given via subcutaneous administration, the therapy will reduce the treatment burden for patients and their caregivers.

Chugai Pharmaceutical president and CEO Dr Osamu Okuda stated: “We are very pleased that crovalimab, our in-house developed project, has been submitted for regulatory approval in Japan for the indication of paroxysmal nocturnal haemoglobinuria.

“Anti-C5 inhibitors are defined as a standard of care in PNH, and subcutaneous crovalimab aims to bring new values.

“A subcutaneous administration of crovalimab once every four weeks in the maintenance phase demonstrated favourable efficacy and safety, bringing a new treatment option which possibly decreases the treatment burden on patients, such as by reducing the dosing time.”

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The submission of the NDA was based on the data obtained from the global Phase III COMMODORE 2 and COMMODORE 1 clinical trials, which were conducted in partnership with Roche.

The open-label, randomised Phase III COMMODORE 2 trial was designed for assessing the safety and efficacy of crovalimab against eculizumab in PNH patients, who have not previously been treated with C5 inhibitors.

The randomised, open-label COMMODORE 1 trial was designed to assess crovalimab’s safety in PNH patients who shifted to crovalimab from other approved C5 inhibitors.