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Gilead's new HCV combo already in the Aussie pipe
Posted 20 July 2017
Australia is likely to see Gilead's once-daily triple combo pan-genotypic hepatitis C therapy approved within six months if the TGA follows the FDA's lead.
Gilead's Vosevi (sofosbuvir/velpatasvir/voxilaprevir) is the first chronic hepatitis C (HCV) treatment approved in the US for patients failed by an NS5A-inhibitor regime such as Sovaldi (sofosbuvir), making it a second-line treatment for people for whom the original drugs did not succeed.
Approval was on the back of trial results showing cure rates of 97 per cent in patients who received Vosevi, which takes existing treatment Epclusa (sofosbuvir/velpatasvir) and adds the new drug voxilprevir.
Gilead revealed in January it had filed the triple combo in Australia - just one month after US filing. The combo was rushed through the US in six months using the Priority Review system, so is unlikely to appear on the ARTG until January 2018.
Despite its rapid Australian filing, the limitation of Vosevi's target market to second-line treatment means it is likely to lag well behind AbbVie in the race to secure additional HVC market share freed up by the demise of the first approved DAAs such as Sovaldi and Harvoni (sofosbuvir/ledipasvir) as they give way to newer pan-genotypic combos.
AbbVie's as yet unnamed pill, which combines glecaprevir and pibrentasvir, went before the PBAC this month and most likely applied for ARTG listing last year. The advantage of AbbVie's latest pan-genotypic offering over Gilead's is that it is only an eight week regimen compared to Vosevi's 12 weeks, and is offered as a first-line treatment.
Gilead is pinning its first-line hopes on Epclusa to secure market share in Australia after it won TGA-listing in December, the same month the PBAC recommended it for listing. Gilead went back to the PBAC this month seeking a change to the listing conditions.
In approving the triple combo, the FDA's Director of the Office of Antimicrobial Products Edward Cox said there was room for a second-line treatment, with Vosevi having been granted both Breakthrough Therapy designation and a Priority Review voucher, allowing it to be approved in just six months rather than the standard 10.
"Direct-acting antiviral drugs prevent the virus from multiplying and often cure HCV. Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past," Cox said.
Vosevi has a boxed warning on its US product label regarding the risk of hepatitis B virus reactivation in co-infected patients.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 20 July 2017
Australia is likely to see Gilead's once-daily triple combo pan-genotypic hepatitis C therapy approved within six months if the TGA follows the FDA's lead.
Gilead's Vosevi (sofosbuvir/velpatasvir/voxilaprevir) is the first chronic hepatitis C (HCV) treatment approved in the US for patients failed by an NS5A-inhibitor regime such as Sovaldi (sofosbuvir), making it a second-line treatment for people for whom the original drugs did not succeed.
Approval was on the back of trial results showing cure rates of 97 per cent in patients who received Vosevi, which takes existing treatment Epclusa (sofosbuvir/velpatasvir) and adds the new drug voxilprevir.
Gilead revealed in January it had filed the triple combo in Australia - just one month after US filing. The combo was rushed through the US in six months using the Priority Review system, so is unlikely to appear on the ARTG until January 2018.
Despite its rapid Australian filing, the limitation of Vosevi's target market to second-line treatment means it is likely to lag well behind AbbVie in the race to secure additional HVC market share freed up by the demise of the first approved DAAs such as Sovaldi and Harvoni (sofosbuvir/ledipasvir) as they give way to newer pan-genotypic combos.
AbbVie's as yet unnamed pill, which combines glecaprevir and pibrentasvir, went before the PBAC this month and most likely applied for ARTG listing last year. The advantage of AbbVie's latest pan-genotypic offering over Gilead's is that it is only an eight week regimen compared to Vosevi's 12 weeks, and is offered as a first-line treatment.
Gilead is pinning its first-line hopes on Epclusa to secure market share in Australia after it won TGA-listing in December, the same month the PBAC recommended it for listing. Gilead went back to the PBAC this month seeking a change to the listing conditions.
In approving the triple combo, the FDA's Director of the Office of Antimicrobial Products Edward Cox said there was room for a second-line treatment, with Vosevi having been granted both Breakthrough Therapy designation and a Priority Review voucher, allowing it to be approved in just six months rather than the standard 10.
"Direct-acting antiviral drugs prevent the virus from multiplying and often cure HCV. Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past," Cox said.
Vosevi has a boxed warning on its US product label regarding the risk of hepatitis B virus reactivation in co-infected patients.
Megan Brodie
megan.brodie@lushmedia.com.au
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