GlaxoSmithKline ($GSK) has notched another FDA approval this week. The agency became the first regulator to stamp an approval on the London-based drugmaker's influenza virus vaccine FluLaval Quadrivalent.
The FDA approved the vaccine, which protects against virus subtypes A and B, for patients aged 3 and older as the company gears up for flu season over the coming months. The quadrivalent intramuscular vaccine is the second such jab to gain an FDA approval after the agency green-lighted its Fluarix Quadrivalent product in December.
Glaxo, which produces more than 30 vaccine products, has pursued development of the vaccine for both strain A subtypes and B subtypes to provide greater protection from the potentially lethal virus than the previous generation of trivalent vaccines that covered just one strain B subtype and both A subtypes, according to the company.
The regulatory win follows fast on the heels of the FDA's approval Monday of GSK's new HIV drug Tivicay, which is expected to be a blockbuster product. The drug, known generically as dolutegravir, is expected to fetch annual sales of more than $1 billion annually.
Unlike dolutegravir, a new integrase inhibitor, flu vaccines have been available for about 50 years. So GSK and other vaccine players are constantly seeking new ways to improve their flu jabs to provide greater coverage against strains, simplified delivery and other advantages.
- here's the release