The U.S. Food and Drug Administration (FDA) approval comes a month after it cleared GSK’s three-in-one inhaler for chronic lung disease. [nL2N1M00AR]
The third new product GSK expects to launch in the world’s biggest drugs market is a dual-drug regimen for HIV, on which the U.S. regulator is scheduled to give a verdict by Dec. 1.
Chief Executive Emma Walmsley, who will present third-quarter financial results on Wednesday, sees the three products as “critical” for GSK’s efforts to fill the revenue gap left by falling sales of the ageing lung drug Advair.
The FDA approved Shingrix, which is given in two doses, for adults aged 50 and over. Approval had been expected after an advisory panel to the agency backed the product.
Shingrix is more effective than Zostavax, the only currently available shingles prevention vaccine, which is given as a single dose. GSK said it expects Shingrix to be “available shortly”.
The U.S. Centers for Disease Control and Prevention’s advisory committee on immunisation practices is expected to vote on a recommendation for the use of Shingrix at its meeting on Wednesday.
The outcome of that meeting may determine just how big the product becomes.
Many analysts expect the committee to recommend routine vaccination of the over-60s, as is currently the case with Zostavax, but an endorsement of use in younger people would represent commercial upside.
Older adults are most at risk of shingles, a painful, often debilitating blistering rash that results from reactivation of the varicella-zoster virus that causes chickenpox and remains latent in those who have had that disease.
Shingrix contains a component from Agenus, which is entitled to royalties on future sales.
Meanwhile, Britain’s National Institute for Health and Care Excellence (NICE) said on Monday that it had approved GSK’s gene therapy Strimvelis for treating ADA-SCID — better known as “bubble boy” disease — despite its…