GSK applies for FDA approval for shingles vaccine

pharmafile | October 24, 2016 | News story | Sales and Marketing GSK, GlaxoSmithKline, Vaccine, chickenpox, shingles 

GlaxoSmithKlien, the UK’s biggest drugmaker, is seeking approval from the FDA for a shingles (herpes zoster) vaccine. The vaccine would be for those of 50 years and above to prevent the emergence of shingles later in life. The vaccine will be known as Shingrix, should it be released onto the market.

Shingles is the reactivation of the chickenpox virus that 90% of people experience during childhood. One in three people, in the US, are likely to have a reactivation of the chickenpox virus that remerges as shingles, this rises to one in two over the age of 85. This higher incidence is thought to be linked to the decline of the immune system or as a consequence of an underlying immunocompromising condition. Shingles is characterised by a painful and itchy rash that usually develops on one side of the body.

GSK’s treatment is backed up by two strong Phase III trials, the results of which were released in April 2015 and September 2016. The two studies held a combined 37,000 subjects globally. In the over-70s, the treatment was found to have an efficacy of close to 90%. The vaccine is given in two intramuscularly doses, with a two to six month interval between doses.

Dr Emmanuel Hanon, senior vice president and head of vaccines R&D, GSK said: “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.”

Shingrix primary competitor is Merck’s Zostavax vaccine. Merck’s is already approved for use in the US but Shingrix’s possible edge comes as Zostavax has shown decreased efficacy over time. In comparison, Shingrix has been shown to remain as effective for at least four years. Bloomsberg analysts project that the drug could make close to $800 million by 2020.

Ben Hargreaves

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