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10/24/2017 - Posted in  Pharmaceutical Affairs

GSK grabs FDA OK for new shingles vaccine, which will now tackle a key Merck franchise

Our expert's opinion

Major achievement for GSK, as they have received FDA's green light to market their newest shingles vaccine. This product is expected to generate a high level of sales, as it has proven during trials to reach higher efficacy than vaccines produced by the competition.

- Matthieu Saintmard, Senior Associate

GSK grabs FDA OK for new shingles vaccine, which will now tackle a key Merck franchise

Watch out Merck. GlaxoSmithKline is coming for a chunk of your shingles vaccine franchise.

Late on Friday the FDA announced that it had green-lighted Shingrix, one of its biggest development programs from the company’s vaccines group. Together with the new COPD three-in-one combo Trelegy Ellipta — approved in September — and an HIV therapy headed to a likely approval, Shingrix represents one of GSK’s best shots at carving our significant new revenue for itself from new products.

The Phase III program for Shingrix was big and expensive, enrolling some 38,000 people to prove that the vaccine had a 90% efficacy rate in preventing shingles.

Merck earned $685 million from Zostavax last year, a vaccine that scored only a 51% rate of protection. GSK, which has a top pharma marketing group, is expected to go after that rival vaccine aggressively in looking to build sales rapidly. And the company, along with some analysts, believe they can do better than Merck, hitting the $1 billion mark in 2022.

With three new products to boast about, but little true innovation seen from its pharma group pipeline, new CEO Emma Walmsley could buy herself some time in revving up a new R&D strategy at GSK, where she recently shook up the pipeline in anticipation of kickstarting a more aggressive approach in the cancer field. GSK’s big cash cow Advair is facing a steadily growing generic threat expected to have a big impact on revenue.

Shingles is triggered by a resurgent varicella zoster virus, which is reactivated as the human immune system gradually weakens with age, exposing it to the painful condition while also spurring postherpetic neuralgia.

Luc Debruyne, president of the global vaccines group at GSK, said:

"We believe Shingrix will provide confidence in the protection one can expect from a shingles vaccine. GSK is committed to partnering with the public health and medical community to help address the gaps in vaccine coverage among adults that persist in the United States."


Source: Endpoints News

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