After picking up key regulatory nods in the U.S., GlaxoSmithKline’s Shingrix is on its way to expanding its reach into Europe. This week, the European Medicines Agency’s CHMP recommended the vaccine for shingles prevention in people 50 and over.
The EMA’s Committee for Medicinal Products for Human Use also recommended the vaccine to prevent post-herpetic neuralgia, a painful shingles complication. The decision now goes to the European Commission, which typically signs off on CHMP nods. GSK says the EC decision is expected by April.
The CHMP's endorsement is a win for GlaxoSmithKline, which has big expectations for its new vaccine. Analysts have predicted more than $1 billion in 2022 sales for the shot, and the company is only in the early stages of its U.S. launch. Along with closed-triple respiratory drug Trelegy and new two-drug HIV therapy Juluca, Shingrix is a near-term focus for the drugmaker, GSK CEO Emma Walmsley has said.
Last fall, Canada became the first country to approve the shingles vaccine, closely followed by the U.S. in October. Then, days later, the CDC’s Advisory Committee for Immunization Practices recommended GSK’s vaccine over Merck’s older Zostavax by an 8-7 vote.
The Merck and GSK vaccines haven't been tested head to head, but studies have shown Shingrix offers higher protection against the infection—90% or higher across all age groups—with the advantage more pronounced in older groups. Merck's vaccine won its FDA approval in 2006.
As GSK works to make the most of its new vaccine on the market, it will have to overtake a Merck shot that pulled in $685 million last year. In a previous interview with FiercePharma, former GSK vaccines executive Moncef Slaoui said the new vaccine will likely steal market share and drive uptake for the class.
A notoriously painful condition that's caused by latent varicella infection, shingles affects about 1 in 3 people in the U.S., according to the CDC. The risk increases with age as immune systems become less able to fend off infections.
Authorities in Australia and Japan are also considering Glaxo's shot for approval.