GSK files shingles vaccine in EU
GlaxoSmithKline has filed its shingles vaccine in Europe, as it seeks to boost sales with a new wave of drugs.
The EU filing of Shingrix follows a US filing last month for the drug, which analysts believe could hit peak annual revenues of $1.5 billion
That's because trials suggest it could offer greater protection against the shingles virus than Merck & Co’s rival, Zostavax.
Shingrix is a non-live, recombinant vaccine, developed to help prevent shingles and its complications.
A phase 3 clinical trial programme showed that by reducing the incidence of shingles, the candidate vaccine also reduced the overall incidence of postherpetic neuralgia, a form of chronic pain associated with shingles.
GSK has developed the vaccine to be given intramuscularly in two doses, with a two-to-six month interval between doses.
The filing for the candidate vaccine is based on a comprehensive phase 3 clinical trial programme evaluating its efficacy, safety and immunogenicity in more than 37,000 people.
This includes the ZOE-50 and ZOE-70 studies published in the New England Journal of Medicine in April 2015 and September 2016, respectively.
Shingrix is one of the more than 40 drugs profiled to investors at GSK’s R&D event in November 2015. Vaccines are one of six core areas of the company's scientific research and development alongside oncology, immuno-inflammation, and infectious, respiratory and rare diseases.
GSK filed the drug with Canadian regulators earlier this month, and a filing in Japan is planned for next year.
Emma Walmsley is set to take over as CEO of GSK when Sir Andrew Witty retires in March next year.
Sales of GSK's big-selling respiratory drug, Seretide/Advair are on the decline because of generic competition, and investors have been underwhelmed by the company's strategy under Witty, including the multi-billion dollar asset swap deal with Novartis.
However GSK's pipeline is starting to deliver, including good news last week concerning its new COPD tripe therapy candidate, which could become a market leader.