GlaxoSmithKline’s shingles vaccine moved one step closer to market after a European Medicines Agency (EMA) panel gave a positive opinion on the drug, which is a key product for the British drugmaker’s pipeline.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing approval for Shingrix, citing the drug’s ability to significantly decrease the incidence of herpes zoster and post-herpetic neuralgia compared with placebo.
CHMP’s opinions are normally endorsed by the European Commission after a review.
In October, the U.S. Food and Drug Administration approved the vaccine for adults 50 and over.
Shingrix is seen as an improvement over Zostavax, the only shingles prevention vaccine available, and sold by Merck & Co.
GSK’s vaccine is considered a key product in its pipeline, with annual sales forecast to reach 1.03 billion pounds ($1.36 billion) by 2023, Thomson Reuters data shows.
Shingrix has shown greater protection against shingles among the elderly than Zostavax. Four years after injection, the Glaxo vaccine remained about 90 percent effective in people over age 70, while the efficacy of Zostavax declines noticeably over time.
Older adults are most at risk for an outbreak of shingles, a painful, often debilitating blistering rash that results from reactivation of the varicella-zoster virus, which causes chickenpox and remains latent in those who have had that disease.
(Reporting by Arathy S Nair in Bengaluru)