European Regulatory Agency Gives AstraZeneca’s Covid-19 Preventative Drug Thumbs Up

Despite having exited the COVID-19 vaccine market this year, pharma giant AstraZeneca has launched its COVID-19 prevention drug, which has received the green light from the European regulatory agency.

Earlier this year, AstraZeneca announced that despite being one of the first companies to release a COVID-19 vaccine and having one of the most popular vaccines for the disease, they would be withdrawing the vaccine from the market, citing the surplus of options available during the post-pandemic era.

Instead, the company shifted its focus towards a preventative drug for the virus, which is named sipavibart.

As of earlier this week, this investigational COVID-19 prevention drug has received the go-ahead from the European Medicines Agency. This approval means that AstraZeneca’s sipavibart now has an approved market authorization application. The company achieved this outcome under an accelerated assessment.

The purpose of an accelerated assessment is to have the EMA review the authorization application as quickly as possible. Through this pathway, the biotech company aimed to get the preventative drug to the relevant individuals as quickly as possible.

According to company representatives, “The EMA’s (European Medicines Agency) Committee for Medicinal Products for Human Use (CHMP) granted sipavibart accelerated assessment as it was deemed of major interest for public health and therapeutic innovation.”

The decision was based on the positive results the treatment generated in a late-stage trial. According to the trial results, sipavibart proved to be efficient in reducing the occurrence of the viral disease in immunocompromised patients. The drug appeared to reduce the risk of infection in patients with weaker immune systems.

In May of 2022, AstraZeneca acquired sipavibart from RQ Bio.

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