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GSK’s shingles vaccine Shingrix claims US approval

Becomes first alternative to Merck & Co’s Zostavax

GSK

GlaxoSmithKline has picked up its second approval for new shingles vaccine Shingrix, a potential blockbuster that is considered key to the company’s near-term financial performance.

The FDA has approved Shingrix for the prevention of shingles in adults aged 50 years and older, and it becomes the first alternative to Merck & Co's Zostavax, which has been on the market since 2006. The vaccine was first approved in Canada earlier this month.

Shingrix is a non-live subunit vaccine administered in a two-dose intramuscular regimen while Zostavax is a live, attenuated vaccine given as a single subcutaneous dose. In trials however Shingrix has shown improved protection against shingles particularly in older people according to GSK, which says its overall efficacy is around 90%.

About one million Americans develop shingles each year, and “the risk and severity of shingles increases with age as the immune system loses the ability to mount a strong and effective response to infection”, said Thomas Breuer, chief medical officer of GSK’s vaccines unit. “Shingrix was developed specifically to overcome the age-related decline in immunity.”

Zostavax is approved by the FDA for use in adults aged 50 years and older, and is recommended by the US Centers for Disease Control (CDC) for adults 60 years and older. While there are no head-to-head trials of the two vaccines, GSK has shown that giving Shingrix to people previously vaccinated with Merck’s shot can restore immunity.

The approval comes after a unanimous vote in favour of approval by an FDA advisory committee last month, and also as Shingrix is under regulatory review in the EU, Australia and Japan. The company says it intends to make the product available in the US shortly at a price of $280 per two-dose course, which is just a few dollars above the list price for Zostavax before discounts.

Shingrix is predicted to become a $1bn-plus product thanks to its improved efficacy over Zostavax, which is on course to reach around $700m in sales this year and has been a reliable earner for Merck for more than a decade. Its future prospects in the US will also depend in part on the outcome of a CDC advisory committee meeting on Wednesday, which will consider the efficacy and cost-effectiveness of the vaccine.

Shingles is caused by the herpes zoster or varicella zoster virus (VZV), which causes chickenpox. While the immune system can generally shake off the symptoms of chickenpox, the virus lies dormant and if a person becomes immune-suppressed then the virus can reawaken, resulting in painful skin lesions. It is increasingly common with advancing age.

Shingrix is one of a trio of new products, along with its closed triple respiratory drug and two-drug HIV regimen. GSK chief executive Emma Walmsley has said the treatments will see the company through a lean product launch spell until its next wave of products from 2022.

Article by
Phil Taylor

23rd October 2017

From: Regulatory

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