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GSK's shingles vax set to arrive in Aust
Posted 14 September 2017
GSK's shingles vaccine Shingrix will likely see an ARTG registration in the next few months if the TGA follows the lead of the US, where an FDA expert panel has unanimously backed the vaccine for market approval.
The panel voted 11-0 in support of the vaccine, which is seeking approval for people aged 50 and over at risk of contracting shingles, with panel members saying that the data showed Shingrix was a "major advance" on the current standard preventative vaccine, MSD's Zostavax.
"Today's vote brings us one step closer to approval of Shringrix, which is specifically designed to overcome age-related weakening of the immune system," Head of Vaccines for GSK Emmanuel Hanon said.
Regulatory review of Shingrix is "underway" in Australia, according to GSK's company statement, suggesting that an ARTG registration could come by the end of this year or early 2018 given the TGA's 12 month review process.
If approved in Australia, GSK has previously said it would also be applying for listing on the national immunisation program where Zostavax, supplied here by vaccine provider Seqirus, is currently available for people aged 70 and over.
Shringrix's potential arrival on the NIP will make it a major challenger to MSD's therapy, which has been bested by the vaccine in clinical trials comparing the two therapies.
Phase III trials had demonstrated the vaccine remained about 90 per cent effective over four years against herpes zoster in patients over 70, whereas Zostavax reduced incidence of the virus by 70 per cent with efficacy noticeably declining over time.
With the head-to-head data significantly favouring the newer vaccine, analysts in the US expect that Shingrix will be a blockbuster therapy and reach USD1 billion by the early 2020s.
GSK filed the therapy in the US last October.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 14 September 2017
GSK's shingles vaccine Shingrix will likely see an ARTG registration in the next few months if the TGA follows the lead of the US, where an FDA expert panel has unanimously backed the vaccine for market approval.
The panel voted 11-0 in support of the vaccine, which is seeking approval for people aged 50 and over at risk of contracting shingles, with panel members saying that the data showed Shingrix was a "major advance" on the current standard preventative vaccine, MSD's Zostavax.
"Today's vote brings us one step closer to approval of Shringrix, which is specifically designed to overcome age-related weakening of the immune system," Head of Vaccines for GSK Emmanuel Hanon said.
Regulatory review of Shingrix is "underway" in Australia, according to GSK's company statement, suggesting that an ARTG registration could come by the end of this year or early 2018 given the TGA's 12 month review process.
If approved in Australia, GSK has previously said it would also be applying for listing on the national immunisation program where Zostavax, supplied here by vaccine provider Seqirus, is currently available for people aged 70 and over.
Shringrix's potential arrival on the NIP will make it a major challenger to MSD's therapy, which has been bested by the vaccine in clinical trials comparing the two therapies.
Phase III trials had demonstrated the vaccine remained about 90 per cent effective over four years against herpes zoster in patients over 70, whereas Zostavax reduced incidence of the virus by 70 per cent with efficacy noticeably declining over time.
With the head-to-head data significantly favouring the newer vaccine, analysts in the US expect that Shingrix will be a blockbuster therapy and reach USD1 billion by the early 2020s.
GSK filed the therapy in the US last October.
Yajun Ma
yajun.ma@lushmedia.com.au
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