GSK Submits FDA Filing for Potential Blockbuster Shingles Vaccine

GlaxoSmithKline is preparing to challenge Merck for control over the shingles vaccine market.

The British drug maker announced on Monday it filed a regulatory application for its vaccine candidate Shingrix.

Clinical trial data indicated Shingrix remained 90 percent effective for about a four year period in people over age 70, which is the group most at risk of contracting this virus, reported Reuters.

Merck’s rival vaccine candidate, Zostavax, has a noticeable decline in older people with an efficacy rate that varies between 18 and 70 percent.

“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. 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,” said Dr. Emmanuel Hanon, the senior vice president and Head of Vaccines R&D for GSK, in a statement.

Analysts predict sales of Shingrix could reach over $1 billion by 2021 while Merck’s Zostavax brought in $749 million in sales for 2015, according to Reuters.

GSK will also submit regulatory filings in Europe and Canada before the end of the year.