The European Medicines Agency (EMA) has granted an accelerated regulatory approval for AstraZeneca’s sipavibart for marketing for the prevention of Covid-19 in immunocompromised patients.
The drug is a long-acting antibody (LAAB) in the study stage, the pharmaceutical company said Monday, designed to provide protection against Covid-19 in immunocompromised patients who do not respond adequately to vaccination and who are at high risk of serious complications from the disease.
The EMA Committee for Medicinal Products for Human Use (CMH) granted this LAAB an accelerated assessment as it was considered to be of high interest for public health and therapeutic innovation. The aim of this accelerated assessment is to reduce the time it takes the CMH to review a Marketing Authorisation Application (MAA) compared to the standard procedure.
The marketing authorisation is based on positive results from the phase III Supernova study, which demonstrated the safety and efficacy of this LAAB in preventing symptomatic Covid-19 in immunocompromised patients compared to controls in a variant panorama in which the Covid-19 cases identified in the study were caused by several different SARS-CoV-2 variants.
Supernova is a Phase III study providing data on the efficacy of pre-exposure prophylaxis against Covid-19 exclusively in immunocompromised patients.
IMMUNOSUPPRESSION
In this regard, Dr. Paul Loubet, professor of infectious diseases at the University of Montpellier, head of the infectious and tropical diseases department at the University Hospital of Nîmes (France) and researcher in the Supernova study, stressed that “the burden of Covid-19 remains high among immunocompromised patients, who suffer disproportionately compared to the general population, despite vaccination.”
“With case numbers expected to increase during the winter months, putting additional pressure on overstretched healthcare systems, this LAAB may be an option for immunocompromised patients who remain at risk and has demonstrated protection against Covid-19 in a mixed environment,” he added.
For her part, AstraZeneca’s executive vice president for vaccines and immunotherapy, Iskra Reich, noted that “immunocompromised patients in Europe currently have no new option to protect themselves from Covid-19 other than vaccination, which is often unavailable. This is enough to protect them from the serious consequences of this disease.”
He therefore added: “We are pleased that the EMA has accepted this regulatory submission with an accelerated assessment procedure and we will work to bring this LAAB to these extremely vulnerable patients.”
PERMISSION OR APPROVAL
Data from the Supernova trial will soon be presented at a scientific forum. In addition to the EMA, AstraZeneca is in dialogue with other regulators about possible paths to authorisation or approval.
Positive SUPERNOVA results showed a statistically significant reduction in the incidence of symptomatic Covid-19 in the antibody-treated group compared to controls, demonstrating a reduction in the relative risk of symptomatic disease caused by any SARS-CoV 2 variant and a relative reduction in the risk of infections caused by SARS-CoV-2 variants that do not contain the F456L mutation.
Overall, the drug was well tolerated during the study, and preliminary analyses showed that side effects were balanced between control groups.