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New flu drugs will miss Aust season
Posted 14 February 2018
As Australia readies for the arrival of a potential new high-dose flu vax, newer breakthrough therapies for the virus are progressing through the pipeline but are unlikely to be in reach locally until 2020 at the earliest.
Sanofi's high-dose Fluzone and Sequiris' adjuvant vaccine Fluad, which appeared on the March PBAC agenda, received an expedited review by the PBAC last month and widely backed to be be available in time for the 2018 flu season.
The two trivalent vaccines were submitted to the committee to be considered for NIP listing for patients over 65 years of age in a special January meeting.
The rush to get them through comes after last year's horror season prompted outcry over the fact that some vaccines, such as Sanofi's high-dose one, were not listed here though they were available overseas.
However some experts have said Fluzone, though it may reduce severity of disease in the elderly, would not have had an impact on the rate of cases experienced last year and to do so would require newer therapies than those we currently have.
Associate Professor Ian Mackay from the University of Queensland said in a Pharmacy News article that "we [would] remain at the mercy of these highly adaptable respiratory viruses," until there was a "universal vaccine".
Meanwhile successive horror flu seasons visiting Northern Hemisphere countries at the moment have also put the spotlight on potential new classes of therapies coming down the pipeline.
Speedy pill therapy
Roche's baloxavir, which it licensed from Japanese pharmaceutical company Shionogi, may be one of these new therapies entering the local market - though it will miss out on the next few seasons for Australia.
The therapy, a single pill treatment of the influenza virus with results showing it could stop the virus in a median time of 24 hours (three times faster than Roche's Tamiflu) is under review in Japan and expected to be filed in the US and EU later this year.
This means an Australian review, if it comes, will be two or three seasons away.
A spokesperson for the company said "if [baloxavir] is approved, Roche will commercialise baloxavir marboxil worldwide (excluding Japan and Taiwan), with Shionogi retaining certain limited co-promotion rights in the US".
"We are currently in discussions with regulatory authorities but as these are confidential, we cannot disclose timings at this time," the company said.
Other therapies in the works include Janssen's anti-flu inhibitor pimodivir, and a universal flu vaccine candidate also in the company's vault, though it still in very early development.
Yajun Ma
Posted 14 February 2018
As Australia readies for the arrival of a potential new high-dose flu vax, newer breakthrough therapies for the virus are progressing through the pipeline but are unlikely to be in reach locally until 2020 at the earliest.
Sanofi's high-dose Fluzone and Sequiris' adjuvant vaccine Fluad, which appeared on the March PBAC agenda, received an expedited review by the PBAC last month and widely backed to be be available in time for the 2018 flu season.
The two trivalent vaccines were submitted to the committee to be considered for NIP listing for patients over 65 years of age in a special January meeting.
The rush to get them through comes after last year's horror season prompted outcry over the fact that some vaccines, such as Sanofi's high-dose one, were not listed here though they were available overseas.
However some experts have said Fluzone, though it may reduce severity of disease in the elderly, would not have had an impact on the rate of cases experienced last year and to do so would require newer therapies than those we currently have.
Associate Professor Ian Mackay from the University of Queensland said in a Pharmacy News article that "we [would] remain at the mercy of these highly adaptable respiratory viruses," until there was a "universal vaccine".
Meanwhile successive horror flu seasons visiting Northern Hemisphere countries at the moment have also put the spotlight on potential new classes of therapies coming down the pipeline.
Speedy pill therapy
Roche's baloxavir, which it licensed from Japanese pharmaceutical company Shionogi, may be one of these new therapies entering the local market - though it will miss out on the next few seasons for Australia.
The therapy, a single pill treatment of the influenza virus with results showing it could stop the virus in a median time of 24 hours (three times faster than Roche's Tamiflu) is under review in Japan and expected to be filed in the US and EU later this year.
This means an Australian review, if it comes, will be two or three seasons away.
A spokesperson for the company said "if [baloxavir] is approved, Roche will commercialise baloxavir marboxil worldwide (excluding Japan and Taiwan), with Shionogi retaining certain limited co-promotion rights in the US".
"We are currently in discussions with regulatory authorities but as these are confidential, we cannot disclose timings at this time," the company said.
Other therapies in the works include Janssen's anti-flu inhibitor pimodivir, and a universal flu vaccine candidate also in the company's vault, though it still in very early development.
Yajun Ma
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