Crovalimab wins 1st regulatory approval for PNH in China

Injections may be self-administered at home for patients ages 12 and older

Steve Bryson PhD avatar

by Steve Bryson PhD |

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The under-the-skin (subcutaneous) injection therapy crovalimab has been approved in China for adults and adolescents, ages 12 and older, with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor medications.

Crovalimab is expected to make treatment more convenient for PNH patients, given that it may be self-administered at home via subcutaneous injections every four weeks, according to a press release from Chugai Pharmaceutical, which is jointly developing the therapy with Roche and its subsidiary Genentech.

“China is the first country in the world to approve crovalimab,” the release stated.

Elsewhere, the U.S. Food and Drug Administration (FDA) is reviewing an application seeking the approval of crovalimab for PNH, with a decision likely sometime this summer. The therapy also is being considered for approval for PNH patients in Japan, as well as in the European Union.

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Crovalimab doses needed less frequently than other PNH treatments

PNH is characterized by the abnormal activation of a part of the immune system called the complement cascade, which leads to blood cell destruction.

Crovalimab is an antibody-based therapy that’s designed to bind to complement protein C5 to prevent the activation of the complement cascade.

Other therapies, such as Soliris (eculizumab) and Ultomiris (ravulizumab), also work by targeting C5 and are approved in the U.S. and other countries to treat PNH. Soliris is administered via an intravenous, or into-the-vein, infusion every two weeks, or roughly twice per month. Meanwhile, Ultomiris can be administered intravenously once every one or two months, or once weekly by subcutaneous injection.

But both are seen to have a greater treatment burden than the approximately once-per-month administration of crovalimab.

Using Chugai’s Recycling Antibody technology, and unlike other C5 inhibitors, crovalimab was developed to bind to its target repeatedly, with the goal of sustainably blocking the complement cascade when given at a low dose by subcutaneous administration every four weeks.

Crovalimab’s approval in China was based on data from several studies, including two ongoing Phase 3 clinical trials: COMMODORE 2 (NCT04434092) and COMMODORE 3 (NCT04654468).

COMMODORE 2, which tested crovalimab against Soliris in more than 200 PNH patients who had never received complement blockers, showed the two therapies were similar in their abilities to control red blood cell destruction, known as hemolysis, and help patients avoid blood transfusions.

Also a Phase 3 trial, COMMODORE 3 enrolled people with PNH, ages 12 and older, without a history of complement inhibitor treatment. That data showed that, like in COMMODORE 2, crovalimab prevented hemolysis, reduced the need for blood transfusions, and eased fatigue.

Crovalimab is the second therapy that applied Chugai’s Recycling Antibody technology to earn regulatory approval, following Enspryng (satralizumab-mwge). That injection therapy for neuromyelitis optica spectrum disorder (NMOSD), was granted such approval in the U.S. and the EU, as well as in other nations.