GSK’s shingles vaccine scores US approval
pharmafile | October 23, 2017 | News story | Sales and Marketing | FDA, GSK, Shingrix, pharma, shingles
GlaxoSmithKline has announced that its shingles vaccine Shingrix (Zoster Vaccine Recombinant, Adjuvanted) has been awarded FDA approval for the prevention of the disease in patients aged 50 or older.
The US regulator’s decision was based upon data generated from a Phase 3 clinical trial programme assessing the medicine’s effects in over 38,000 patients. Throughout the studies, Shingrix demonstrated a 90% efficacy and sustained efficacy over a four-year follow-up period. As a consequence of preventing the development of shingles in patients, the drug also lowered the overall incidence of postherpetic neuralgia, a chronic nerve pain condition.
“Shingrix represents a significant scientific advancement in the field of vaccinology. The vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a painful and potentially serious disease that affects 1 in 3 people in the United States,” explained Dr Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines. “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. Shingrix was developed specifically to overcome the age-related decline in immunity.”
In September, Shingrix received unanimous recommendation from an FDA advisory panel. Following this latest decision, the vaccine is expected to be made available on the market very soon.
Luc Debruyne, President of Global Vaccines at GSK added: “We believe Shingrix will provide confidence in the protection one can expect from a shingles vaccine. GSK is committed to partnering with the public health and medical community to help address the gaps in vaccine coverage among adults that persist in the United States.”
Matt Fellows
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