- Two positive European Medicines Agency reviews
- RSV market to reach $5bn, HIV injectables market £26bn
- Shares gain 1.7%
Shares in global biopharma firm GSK (GSK) got a shot in the arm on Friday after the company said the EMA (European Medicines Agency) had accepted a marketing authorisation application for the company’s RSV vaccine candidate and validated an application for its long-acting HIV drug.
The shares gained 1.7% to £14.10 on the news, though they are down around 12% year-to-date.
Respiratory syncytial virus is a common contagious virus which attacks the lungs and breathing passages. Older patients with pre-existing medical conditions are particularly at risk.
The company said the EMA had accepted its RSV marketing authorisation application under accelerated assessment.
Marketing authorisation applications may be eligible for accelerated assessment where the product is of ‘major interest for public health and therapeutic innovation’. A decision is expected in the third quarter of 2023.
Today’s announcement is the second regulatory milestone for the vaccine following the acceptance of a submission in Japan in October 2022.
The application was based on positive phase three data showing the vaccine was effective against respiratory syncytial virus-lower respiratory tract disease in adults aged 60 years and above with a favourable safety profile.
RSV remains one of the few major infectious diseases without an approved vaccine.
Analysts at investment bank Berenberg believe the strong efficacy of GSK’s RSV vaccine puts the company in a leading position in the race to secure a stake in the circa $5 billion older-adult RSV vaccine market.
HIV SUCCESS
In a separate announcement, GSK said the European Medical Agency had validated a marketing authorisation application for its long-acting injectable HIV prevention drug cabotegravir.
The company said cabotegravir is the first and only long-acting option proven superior to daily oral tablets. The drug was developed by GSK’s majority owned ViiV Healthcare.
ViiV expects cabotegravir to take significant market share from competing oral treatments such as Gilead’s (GILD:NASDAQ), which dominates the market.
By 2026 ViiV estimates cabotegravir sales will top £2 billion and the overall market to be worth around £26 billion in the long term.
