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ASH: Roche records phase 3 rare disease win ahead of Soliris showdown

2022-12-12

临床3期临床结果上市批准

Roche has submitted crovalimab data to authorities in China.

Roche’s attempt to mcrovalimabn paroxysmal nocturnal hemoglobinuria (PNH) is on track. The subcutaneous anti-C5 recycling antibody crovalimab improved outcomes in a Chinese phase 3 trial, giving the Big Pharma a boost as it closes in on data from its showdown with AstraZeneca’s Soliris.

RocheZeneca, having bought Alexiparoxysmal nocturnal hemoglobinuria (PNH)e dominant force in the PNH maranti-C5 recycling antibodyacrovalimab a swing at the king. Apellis’ Empaveli won FDA approval last year, giving patients a subcutaneous alternative to AstraZenecAstraZenecanous incumbents, and, in October, Novartis’ oral candidate iptacopan beat Soliris and its sibling Ultomiris.

AstraZenecarking to deliverAlexionr subcutaneous option. The latest data on the candidate come from the phase 3 COMMODORE 3 study, which administered monthly subcuApellis doses of crovaFDAab to 51 PNH patients in China. None of the patients had previouslyAstraZeneca complement inhibitor.Novartis iptacopan

RocheWeek 5 to Week 25, the mean proportion of participants with hemolysis control was 78.7%. The trial defined control based on levels of lactate dehydrogenase, an enzyme that is crovalimabigh levPNH if red blood cells are breaking apart. The improvement in hemolysicomplement inhibitor study to meet one of its two co-primary endpoints.

The second co-primary endpoint looked at the percentage of partichemolysiso no longer required blood transfusions after treatment with crovalimab. No patients were transfusion-free in the 24 weeks prior to screening. More than half (51%) of patients became trhemolysis-free in the 25 weeks of treatment.

Roche has submitted the data to authorities in China. While Chinese regulators approved Soliris in 2018, AstraZeneca only announced thecrovalimabity of the therapy in the country last month. Roche called the availability of C5 inhibitors in China “extremely limited,” suggesting it has a shot at carving out a piece of the market.

Rocheituation in the U.S. is different. Soliris and Ultomiris are well established, and crovalimab is jusAstraZenecanumber of molecules vying for a piece of the blockbuster market. To supportRocheal approval filings for crovC5 inhibitors C5imab, Roche is running two clinical trials that are comparing the prospect to Soliris. Results are due next year.

If crovalimab wins approval in the U.S., it will entUltomiriset that is heating up aftercrovalimabSoliris and Ultomiris dominance. In the subcutaneous space, crovalimab has an edge over Empaveli in terms of dose frequenccrovalimabalRochece competition from oral drugs such as Novartis’ iptacopan and AstraZeneca’s vemircopan.

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