GlaxoSmithKline announced Friday that it submitted a marketing application to the European Medicines Agency seeking approval for its candidate shingles vaccine Shingrix for the prevention of herpes zoster in people aged 50 years or over. The filing follows submissions to the FDA in October and to Canadian regulators earlier this month, with a Japanese application planned for 2017.
According to GlaxoSmithKline, the EMA filing is based on a Phase III clinical trial programme involving more than 37 000 participants, including data from the ZOE-50 and ZOE-70 studies, both of which have been published in the NEJM. Results from ZOE-50 showed that a two-dose schedule of Shingrix, also known as HZ/su, reduced the risk of herpes zoster by 97.2 percent in adults aged 50 years and older compared to placebo, while in the ZOE-70 trial, it demonstrated 90-percent efficacy against shingles versus placebo in people aged 70 years and over. The company has also reported that Shingrix was 89-percent effective against postherpetic neuralgia.
Emmanuel Hanon, head of vaccines R&D at GlaxoSmithKline, said Shingrix "has consistently shown high efficacy in older people in its Phase III development programme," adding that the latest regulatory filing "puts us a step closer to making this vaccine available to help protect more people from shingles and the complications associated with it."
GlaxoSmithKline noted that a clinical study is underway to evaluate revaccination in people who have already received the currently available live-attenuated shingles vaccine. The company added that trials are also being conducted in populations at high risk for shingles, including patients with solid and haematological cancers, haematopoietic stem cell and renal transplant recipients and those infected with HIV.
The UK drugmaker last year cited Shingrix as one of up to 20 new products that it was aiming to submit for regulatory approval by 2020.
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