GlaxoSmithKline has the official go-ahead for its next big launch. Late Friday, the FDA approved the company's new shingles vaccine, Shingrix, setting up a market duel with blockbuster implications between GSK and Merck.
FDA approved Shingrix for people aged 50 and older as an immunization against the notoriously painful condition that's caused by latent varicella infection. The nod comes one month after an outside group of experts voted unanimously in favor of approval and just days after Canada became the first country to license the shot.
GSK and analysts have high hopes for Shingrix. New CEO Emma Walmsley has said it's one of three launches that are a near-term focus for the drugmaker, and market watchers think the vaccine can reach blockbuster status by 2022.
To get there, it'll have to overtake Merck's Zostavax, which won FDA approval in 2006 and has dominated the market since. Merck's shot, which many experts see as inferior to Glaxo's, reeled in $685 million last year. In a previous interview with FiercePharma, Moncef Slaoui, ex-vaccines exec at GSK, said he believes Shingrix will likely steal share and drive uptake in the class.
In recommending the vaccine last month, an FDA panel expert said Shingrix is “a lot better than the vaccine we have now,” referencing Merck’s Zostavax. Investigators haven't conducted head-to-head studies, however.
Along with a closed triple respiratory med and a two-drug HIV regimen, Shingrix is one of three launches GSK is emphasizing as a near-term focus. The U.K. pharma giant recently won FDA approval for its blockbuster respiratory candidate Trelegy—which incorporates three COPD meds in one inhaler to increase convenience for patients—and earlier this year submitted a two-drug HIV regimen to U.S. and EU regulators. The company says a U.S. decision on the HIV med is expected in December.
Ahead of the approval, the company has worked to build the case for Shingrix by touting data showing its vaccine offers lasting protection and can provide protection for those who’ve previously received Zostavax. Earlier Zostavax studies showed that vaccine's protection wanes over time.
Up next for Shingrix is an important meeting next week at the CDC's Advisory Committee on Immunization Practices, which recommends vaccine policy. The group has a Shingrix consideration (PDF) on its October agenda, with a vote expected on Wednesday.