GSK seeks EU green light for potential blockbuster Shingrix

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GlaxoSmithKline has filed for EMA marketing authorization for its shingles vaccine, Shingrix.

On the heels of its first Shingrix application in the U.S., GlaxoSmithKline is setting out for European approval for a vaccine that analysts think might be able to hit blockbuster sales in the coming years.

GSK’s Shingrix application with the European Medicines Agency seeks marketing authorization for the shot to prevent herpes zoster in people aged 50 and older. If it’s approved, the vaccine would be given in two doses between two and six months apart.

Shingrix carries big expectations for the London pharma giant. Vaccines head Moncef Slaoui has previously said the product represents a potential “major” market disruptor upon its introduction. If approved, the vaccine would see market share gains and drive uptake in the class, “which today is quite limited in the older population,” Slaoui previously told FiercePharma.

Analysts seem to agree, having pegged peak sales at about $1 billion by 2022 for the vaccine, according to EvaluatePharma’s World Preview 2016. Shingrix would challenge Merck’s Zostavax on the market, which pulled in $749 million in sales last year for the New Jersey company.

Though the Merck and GSK vaccines haven’t been tested head-to-head, Shingrix has posted higher, lasting efficacy numbers in clinical trials. Zostavax’s efficacy wanes within the first 5 years in people 60 and over.

Glaxo’s EMA app comes shortly after the company filed for approval in the U.S. and Canada and ahead of a Japanese submission planned for next year.

EvaluatePharma sees Shingrix as the second most valuable R&D project in vaccines by 2022, trailing Novavax’s preclinical combination respiratory program.

Slaoui additionally figures the vaccine’s adjuvant could be used to create other vax solutions for elderly people with efficacy "in the 90s rather than in the 50s and 60s,” he told FiercePharma.