AstraZeneca files rival to Pemgarda for COVID PrEP

 AstraZeneca may have exited the COVID-19 vaccine market, but it is still hoping to protect vulnerable patients with its antibody sipavibart for pre-exposure prophylaxis (PrEP).

The drugmaker said this morning that an application for sipavibart (AZD3152) has been accepted for review by the EMA as PrEP for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.

There is currently one antibody available for PrEP in COVID-19 – Invivyd’s Pemgarda (pemivibart) – which was granted emergency use authorisation (EUA) in the US in March for adults and adolescents who are moderately-to-severely immunocompromises.

So far, Pemgarda is not available outside the US, and immunocompromised patients currently have no options for COVID-19 protection in Europe beyond vaccination.

AZ said the EMA’s human medicines committee, the CHMP, has granted sipavibart accelerated assessment “as it was deemed of major interest for public health and therapeutic innovation.” The company is also discussing marketing applications with other regulatory authorities.

The filing comes as there are discussions about a possible ‘summer wave’ of COVID-19 in Europe and the US, with a slight increase in the number of people being hospitalised with the disease that seems to be driven by people aged 85 and over. The uptick has coincided with the emergence of a new group of variants of COVID-19, collectively known as FLiRT, that includes strains like JN1, KP2, and KP3.

According to AZ’s INFORM real-world evidence study, immunocompromised people accounted for about 25% of COVID-19 hospitalisations, intensive care admissions and deaths, but only made up around 4% of the overall study population.

“The disease burden of COVID-19 remains high for immunocompromised patients who are disproportionately impacted compared to the general population, despite vaccination,” said Prof Paul Loubet, an infectious diseases specialist at the University of Montpellier in France.

“With cases expected to rise in the winter months, adding more pressure to stretched healthcare systems, sipavibart has the potential to be an important option for immunocompromised patients who remain at risk.”

Prof Loubet was an investigator in AZ’s SUPERNOVA trial of sipavibart, which demonstrated protection from symptomatic COVID-19 with the antibody in a mixed variant environment compared to control.

According to AZ, SUPERNOVA is the only phase 3 trial with efficacy data for COVID-19 PrEP carried out exclusively in immunocompromised patients.

Invivyd said earlier this year it expects Pemgarda to make sales of between $150 million and $200 million in 2024.

https://pharmaphorum.com/news/astrazeneca-files-rival-pemgarda-covid-prep