GSK seeks FDA approval of new shingles vaccine

GlaxoSmithKline (LSE: GSK) has filed a Biologics License Application (BLA) to the US Food and Drug Administration for its shingles vaccine Shingrix, which it hopes will best a competitor from Merck & Co (NYSE: MRK) and net more than $1 billion in yearly sales by 2020.

The UK pharma major is specifically seeking approval for the prevention of shingles (also known as herpes zoster) in people aged 50 years or over, with the submission to the US regulator backed by strong Phase III trial data from more than 37,000 individuals.

Shingles is an infection of a nerve and the surrounding skin, which most commonly affects older people. It is caused by the same virus as chickenpox, which remains dormant in the nervous system years later, and can be reactivated if the immune system is compromised - a risk which increases with age. The condition can cause a rash and painful blisters which can scar and also lead to vision problems. The vaccine works by boosting the immune system.