GlaxoSmithKline is seeking FDA approval for its new shingles vaccine, a drug that analysts say could be a $1 billion-a-year blockbuster.

GSK, which has major operations across the Triangle, says the vaccine known as Shindrix would target prevention of herpes zestor, or shingles, in people age 50 and older.

The vaccine performed very well in Phase 3 clinical trials.

Analysts polled by Thomson Reuters expect the drug to top $1 billion in revenue by 2021.

If approved, Shindrix would compete with Zostavax, a near $750 million-a-year seller in the U.S. It is made by Merck.

“Shingles is a common and potentially serious condition. It can cause lasting pain and other complications such as scarring or visual impairment, which can severely impact the quality of people’s lives,” said Dr. Emmanuel Hanon, GSK’s head of Vaccines R&D, in the announcement which was made in London.

“The risk of developing shingles increases with age and it is estimated that up to one in every three people is at risk. Today’s file submission puts us a step closer to making this vaccine available to help protect more people from shingles and the complications associated with it.”

GSK’s description

GSK described the vaccine this way:

“The candidate vaccine is a non-live, recombinant vaccine to help prevent shingles and its complications. The phase III clinical trial programme showed that by reducing the incidence of shingles, the candidate vaccine also reduced the overall incidence of postherpetic neuralgia (PHN), a form of chronic pain associated with shingles. Regulatory approval is being sought for the vaccine to be given intramuscularly in two doses, with a two to six month interval between doses.”

GSK (NYSE: GSK) also is seeking approval for the vaccine in Canada and the EU.

The Phase 3 trial included more than 37,000 people.

Read the full announcement at: