GSK applies for EU approval for shingles vaccine
pharmafile | November 28, 2016 | News story | Sales and Marketing |Â Â European Commission, GSK, GlaxoSmithKline, Shingrix, shinglesÂ
After filing for FDA approval in October, GlaxoSmithKline has now applied for approval from the European Commission (EC) for its shingles (herpes zoster) treatment Shingrix.
These regulatory moves are based on the vaccine’s successes in a 37,000-participant Phase 3 clinical trial which found that, compared to placebo, Shingrix reduced the risk of contracting herpes zoster by 97.2% in patients over 50 years old, as well as proving a 90% efficacy rate in those aged 70 or over.
Emmanuel Hanon, head of vaccines, R&D at GSK commented on the strength of the findings: “Shingrix has consistently shown high efficacy in older people in its Phase III development programme. [The EC application] puts us a step closer to making this vaccine available to help protect more people from shingles and the complications associated with it.”
The data potentially puts Shingrix ahead in the efficacy stakes versus rival Zostavax by Merck, which has shown to lose effectiveness over time, which GSK’s product stays effective for at least four years.
Shingles, a reactivation of the chickenpox virus later in life, is a potential threat to a third of US citizens, particularly the elderly, with the risk being 50% in those aged 85 and older.
The treatment was also submitted for approval to Canadian regulators this month, with the company planning to apply for Japanese approval next year. Analysts believe the treatment could be worth as much as $800 million by 2020.
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