GSK Secures EU & Japanese Approvals For Shingrix
Executive Summary
Hot on the heels of the FDA approval, GlaxoSmithKline has received the green light for its shingles vaccine Shingrix from both the EU Commission and the Japanese Ministry of Health, Labour and Welfare but it is remaining tightlipped about its commercialization plans.
Officials at the European Commission and Japan’s Ministry of Health, Labour and Welfare (MHLW) have approved Shingrix, the GlaxoSmithKline PLC non-live, recombinant subunit vaccine, for the prevention of shingles in adults aged 50 years or older. The EC has also approved Shingrix for the prevention of post-herpetic neuralgia (PHN) for the same patients.
The approvals are expected to put more pressure on Zostavax, the Merck & Co. Inc. shingles vaccine, which saw a dramatic drop off in sales in the US following FDA approval of Shingrix in October 2017 and the subsequent recommendation by US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices naming Shingrix as the preferred vaccine for the prevention of herpes zoster and related complications for immunocompetent adults aged 50 years and older (Also see "Shingrix Seen Replacing Zostavax In EU & US as Shingles Standard Of Care" - Scrip, 31 Jan, 2018.).
MSD saw a 45% year on year decline in US sales of Zostavax in the fourth quarter from $221m in 2016 to $121m in 2017. In the same period, GSK reported sales of $22m. Since 2015, MSD has seen US sales of Zostavax fall from $592m in 2015 to $518m in 2016 and $422m in 2017. Datamonitor Healthcare analysts forecast that global sales of Shingrix could hit $687m by 2025.
Datamonitor Healthcare analyst Michael Haydock thinks that Zostavax sales could drop off faster than originally forecast. “I can’t see the 5EU countries continuing to recommend two different vaccines in the long term, particularly when one vaccine is clearly superior to the other. Instead, I suspect we will find that the 5EU countries will just procure one recommended vaccine (Shingrix), as they will presumably get a better price per dose if they exclusively reimburse it,” he told Scrip.
For Japan, Haydock believes Shingrix may have an open goal as Zostavax is currently not routinely recommended in the elderly. “I assume the reason Zostavax isn’t used is because it is not deemed cost effective in Japan, its efficacy declines with age, but Shingrix should have a stronger case given its superior efficacy,” he added.
In the ZOE-70 study, Shingrix was shown to be 97% effective in preventing herpes zoster in those aged over 50 years, and 90% effective in adults aged over 70 years. Conversely, Zostavax’s efficacy declines steeply with age, with the CDC estimating it is only 38% effective in those aged above 70 years, and protection also wanes substantially within four years post vaccination.
GSK declined to provide details of how it intends to roll out the vaccine – in Japan it is registered to the Japan Vaccine Co. Ltd., a joint venture of GlaxoSmithKline and Daiichi Sankyo Co. Ltd. – saying it will be able to provide more information on launch plans in due course following national level discussions. “GSK looks forward to launching the vaccine on a country by country basis as and when we are in a position to provide sustainable supply to meet local demand,” a GSK spokesperson told Scrip.