- FDA accept review of syringe application
- Over 90 million doses given
- Approved expected by 20 June 2025
The US FDA (Food and Drug Administration) has accepted for review the regulatory application of GSK’s (GSK) pre-filled syringe presentation of its shingles prevention drug Shingrix.
The new application removes the need for healthcare professionals to reconstitute separate bottles prior to administrating the drug.
The company said over 90 million doses of the vaccine have been distributed since it was approved in the US in 2017. An FDA decision is expected by 20 June 2025.
The shares ticked up 2p or 0.15% to £13.51 and are down around 14% over the last year compared with a 7% gain in the FTSE 100 index.
MORE CONVENIENCE
Currently the process for administering the vaccine consists of a physician mixing a dry powder with a liquid accelerant. The new presentation has the same composition as the reconstituted vaccine and the FDA submission is based on data demonstrating comparability between the two methods.
GSK said today’s announcement represents an important regulatory milestone for the shingles vaccine and reflects the company’s ‘continued innovation on its commercialised portfolio to meet the needs of the healthcare community’.
Shingles is a painful, blistering rash that can last for weeks and is caused by the reactivation of the same virus which causes chickenpox. People over the age of 50 are particularly at risk as the strength of the immune system weakens with age.
Shingrix generated sales of £2.5 billion for GSK through to the third quarter of 2024 with penetration outside the US representing 58% of sales with average immunisation rates of 6%. US immunisation is around 39% of the 120 million adults currently recommended to receive the vaccine.
