Planning to challenge an entrenched product from Merck, GlaxoSmithKline on Monday filed the first licensing application for its shingles vaccine, Shingrix.
The British pharma submitted a Biologics License Application with the FDA for a vaccine that analysts have said could reel in more than $1 billion by 2021, according to a Thomson Reuters consensus. Last year, Merck’s shingles vaccine Zostavax pulled in $749 million in sales. Zostavax first won FDA approval in 2006.
In its app, GSK cited data from two Phase III trials, ZOE-50 and ZOE-70, testing the vaccine in more than 37,000 people. In ZOE-50, a study of 16,160 adults 50 and older, the vaccine posted an efficacy of 97.2%. The ZOE-70 trial demonstrated that Shringix’s 90% efficacy in adults 70 and older lasted at least four years.
Now, GSK is seeking marketing approval for adults 50 and older. The vaccine would be given in two doses between two and six months apart.
The shot represents a “major” market disruptor, GSK vaccines head Moncef Slaoui previously told FiercePharma, if it’s approved by the FDA. That’s because it would see market share gains and also drive “uptake of the vaccine, which today is quite limited in the older population,” he said.
If its FDA label includes Shingrix’s ability to provide long-lasting protection, that could be an avenue for GSK to grab market share from Merck. Though the two vaccines haven’t been tested head-to-head, Zostavax posted lower efficacy numbers in its clinical trials, and its efficacy wanes within the first five years in people 60 and over. Doctors and public health officials do consider trial-data differences.
In its own studies, Zostavax showed a 64% reduction of herpes zoster in people aged 60 to 69, a number that fell to 41% in the 70-to-79 age range and 18% for those 80 and older.
Next up for GSK’s vaccine are filings yet this year in the EU and Canada, with a Japan application planned for next year.
What’s more, Slaoui has said, is that Shingrix’s adjuvant could be used to create other vaccines for elderly people with efficacy "in the 90s rather than in the 50s and 60s,” he told FiercePharma.
The application comes just days after FiercePharma learned that GSK pulled out of the U.S. with its HPV vaccine Cervarix, conceding that market to Merck’s blockbuster Gardasil franchise.
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