GSK reports PhIII success for shingles jab, will file for approval in late 2016
Merck's ($MRK) Zostavax is the only shingles vaccine approved in the U.S. and EU, but it may not be for long. Based on results from two Phase III trials involving more than 16,000 older adults, GlaxoSmithKline ($GSK) plans to submit a regulatory filing for its shingles candidate, dubbed Shingrix, in North America, Japan and the EU in the second half of 2016.
The British pharma announced Tuesday the results from a Phase III trial involving adults aged 70 and older. The vaccine demonstrated 90% efficacy compared with placebo. This builds on the 97.2% efficacy compared with placebo that the candidate achieved in an earlier Phase III trial involving adults aged 50 and older.
And in the case that a vaccinated individual does catch shingles, the vaccine can ward off a potentially painful and long-lasting complication that can follow shingles: postherpetic neuralgia (PHN). Shingrix showed 89% efficacy in preventing PHN in adults over 70 and 91% efficacy in preventing it in adults over 50.
"Together, these remarkable results underscore the potential of the candidate vaccine to prevent both shingles and PHN in older adults," said Dr. Alain Brecx, vaccine development leader at GSK. "About 90% of people 50 years and over are at risk of developing shingles, a painful disease that negatively impacts people's health and quality of life."
Its efficacy in older adults gives Shingrix a potential leg up over Merck's Zostavax, whose efficacy declines in older people.
After approval, Shingrix would be "well positioned to capture market share from Zostavax," wrote Cowen & Co. analysts in a note in April this year. The analysts made sales forecasts for the vaccine of £10 million ($14.8 million) in 2017 and £75 million ($111 million) in 2020.
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