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A long-acting antibody, sipavibart, designed to neutralize the interaction of the spike protein with the ACE2 receptor, offers coverage against Omicron and other ancestral viral variants.
Approved by RQ Biotechnology in May 2022, the antibody evolved to protect immunocompromised people against Covid-19. These patients are at increased risk of suffering serious consequences from the disease.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted sipavibart an accelerated assessment due to its prospects for public utility and as a curative innovation.
The presentation of sipavibart discusses the positive effects of the phase III SUPERNOVA clinical trial.
This international, double-blind, randomized, placebo-led trial looked at the efficacy and protection of sipavibart compared to (tixagevimab/cilgavimab or placebo).
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The Covid-19 variants observed in the trial included several other SARS-CoV-2 strains.
Sipavibart prevented symptomatic Covid-19 in immunocompromised people compared to the group.
AstraZeneca is also working with other regulatory bodies to discuss potential pathways for clearance or approval of sipavibart.
Iskra Reic, executive vice president of Vaccines and Immunological Therapies at AstraZeneca, said: “Immunocompromised patients currently have no protective features against Covid-19 in Europe beyond vaccination, which is not sufficient to protect them against the serious consequences of the Covid. -19.
“We are very pleased that the EMA has accepted this regulatory submission with an accelerated evaluation procedure and we will work to bring sipavibart to those highly vulnerable patients.
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