GlaxoSmithKline plc (ADR) (NYSE:GSK)’s Shingles Vaccine Likely To Get FDA Approval In Coming Weeks

An advisory panel of the U.S. Food and Drug Administration has voted unanimously to approve a shingles vaccine known as Shingrix that has been developed by GlaxoSmithKline plc (ADR) (NYSE:GSK) for use in adults above the age of 49. Members of the advisory panel expressed their satisfaction with the efficacy data that emerged from the clinical trials of the vaccine. According to the panel, the efficacy of Shingrix was an improvement from Merck & Co., Inc. (NYSE:MRK) Zostavax, the only other marketed vaccine for preventing shingles.

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Though the Food and Drug Administration is not under any obligation to abide by what its advisory panels have recommended the enthusiasm expressed is an indication that approval of the vaccine is almost guaranteed in the coming weeks.

Blockbuster status

In GSK’s portfolio of drugs that are in the pipeline, Shingrix ranks highly in importance since it is projected to reach blockbuster status in six years’ time. Zostavax received FDA approval a little over a decade ago and is this year forecast to reach sales of approximately $730 million. Competition in the coming years is however expected to lead to declining sales in the ensuing period.

A shingles outbreak is more likely to happen to older people. The disease occurs when the virus responsible for causing chickenpox, varicella-zoster, is reactivated. In people who have suffered from chickenpox, the virus remains dormant.

More protection

During the clinical trials, Shingrix demonstrated that it offered more protection against shingles in older recipients compared to the efficacy offered by Zostavax. In the case of Shingrix the vaccine was still around 90% effective among the 70-and-over age group four years after the injection. The effectiveness of Zostavax, on the other hand, declined over time.

“This is a new generation of vaccine, which really has overcome the age-related decline in immunity,” said GSK Vaccines’ chief medical officer, Thomas Breuer, in an interview with Reuters.

Besides GSK, Agenus Inc is also expected to benefit once Shingrix gets to the market as the firm is entitled to royalties since it owns the rights to the component that boosts efficacy in the vaccine.

On Wednesday shares of GlaxoSmithKline Plc fell by 0.67% to close the day at $40.10.

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