The European Medicines Agency (EMA) has accepted AstraZeneca’s Marketing Authorisation Application (MAA) for sipavibart under an accelerated assessment procedure to prevent Covid-19.
Sipavibart is a long-acting antibody under investigation, aiming to offer Covid-19 protection.
AstraZeneca seeks European approval for sipavibart for the pre-exposure prophylaxis of Covid-19 in immunocompromised patients.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted sipavibart accelerated assessment due to its significant public health interest and therapeutic innovation.
Accelerated assessment aims to expedite the review timeframe for sipavibart’s MAA compared to standard procedures.
The MAA is supported by positive findings from the SUPERNOVA Phase 3 trial.
The trial demonstrated sipavibart’s safety and effectiveness in preventing symptomatic Covid-19 in immunocompromised patients, compared to a control group.
It met both dual primary endpoints and showed a statistically significant reduction in the incidence of Covid‑19.
SUPERNOVA is said to be the only Phase 3 trial providing efficacy data for Covid-19 pre-exposure prophylaxis exclusively in immunocompromised patients.
AstraZeneca vaccines and immune therapies executive vice president Iskra Reic said: “Immunocompromised patients currently have no options for Covid-19 protection in Europe beyond vaccination, which often is not sufficient to protect them against serious Covid-19 outcomes.
“We are pleased that the EMA has accepted this regulatory submission with an accelerated assessment procedure and will work to bring sipavibart to these highly vulnerable patients.”
In addition, AstraZeneca is discussing potential authorisation or approval pathways for sipavibart with other regulatory authorities.
In a separate development, CHMP recommended approval for AstraZeneca’s Imfinzi (durvalumab) and Lynparza (olaparib) combination to treat certain patients with primary advanced or recurrent endometrial cancer.
The recommended treatment sequence includes Imfinzi plus chemotherapy as first-line therapy, followed by Lynparza and then Imfinzi, for patients with mismatch repair proficient (pMMR) disease.
For patients with mismatch repair deficient (dMMR) disease, the recommendation is Imfinzi plus chemotherapy followed by Imfinzi alone.
The positive opinion was based on a prespecified exploratory subgroup analysis of mismatch repair (MMR) status from the DUO-E Phase 3 trial.
Last month, the US Food and Drug Administration (FDA) approved AstraZeneca’s Imfinzi, chemo combo for dMMR endometrial cancer.
