AstraZeneca’s infant RSV drug Beyfortus could generate $1.1bn sales revenue

AstraZeneca’s infant RSV drug Beyfortus could generate $1.1bn sales revenue

AstraZeneca and Sanofi could make $1.1bn in sales revenue if its infant RSV drug Beyfortus (nirsevimab) is approved. 

Today, Beyfortus was recommended for approval in the European Union by a European Medicines Agency committee for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in newborn babies and infants during their first RSV season. 

This is the first in a series of likely breakthroughs in the global RSV market. 

Aifinity expects the price per course to be $600 in the US and $300 in Europe. AstraZeneca and Sanofi are pushing for Beyfotus to be used in all children; which could be up to 3.5 million infants under one year of age in Europe. This would generate a potential revenue of up to $1.1bn.

It is estimated that the healthcare saving (excluding the cost of the treatment) could be around $300M, as such treating the infant population could incur a net cost of around $800M, should the price be $300 per course. However, if the price were $85 or lower, then there could be net healthcare savings in Europe.

Following a post opinion phase of a maximum of 67 days, the European Commission will vote on the approval, which almost always follows CHMP opinion. 

Airfinity expects the review period to be shorter and for Beyfortus to potentially gain marketing approval before mid-November. Beyfortus, if approved, would be the first and only single-dose treatment for the broad infant population. The only currently available treatment for RSV is palivizumab, but this is only used in high-risk groups due to its high price. Beyfortus is expected to be less expensive and more widely available. 

Dr Sam Campbell, life science analyst at Airfinity, says, “AstraZeneca and Sanofi will have first to market advantage among next generation paediatric RSV prophylaxis. This advantage is more pronounced for larger pharma companies, with estimates of an average 10-20% higher than fair market share over the second entrant, even when being outspent on marketing. 

“Other candidates, such as clesrovimab from Merck MSD, or Pfizer’s paediatric RSVpreF formulation, will likely need to show a significant advantage in terms of price, logistics, or efficacy.”