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Gilead files Hep C triple combo
Posted 31 January 2016
Gilead has filed its latest hepatitis C triple combination therapy with the TGA with a decision likely to be made by January 2018.
The sofosbuvir/velpatasvir/voxilaprevir combination has been filed for approval as a treatment option in all six hepatitis C genotypes. If approved, it could further lengthen Gilead's lead over its rivals in claiming much of the growth in PBS revenue.
Gilead confirmed it had lodged an application with the TGA for the registration of the hepatitis C combination, with the filing following quickly after it was submitted overseas.
The triple combination was filed with the FDA in December and in Europe earlier this month. The EMA granted it accelerated review status, potentially hastening approval. Unlike Europe and the US, Australia does not provide an accelerated approval option.
In the US it has been granted breakthrough therapy designation in chronic genotype 1 patients who have previously failed an NS5A inhibitor-containing regimen.
The triple combination therapy is a once daily, single tablet 12-week regimen for genotypes 1 to 6 without cirrhosis or with compensated cirrhosis.
Global filings are being supported by data presented at the American Association for the Study of Liver Diseases annual meeting in November 2016 showing 97 per cent cure rates across all genotypes, including patients who failed on other treatments.
Gilead emerged as the big winner in PBS spending growth last year with its products generating $2.21 billion in PBS benefits (before rebates). Its leading hepatitis C products Sovaldi (sofosbuvir) and Harvoni (ledipasvir /sofosbuvir) were both PBS listed in March, considerably boosting the company's Australian revenue.
Gilead is looking to continue its local revenue growth with its most recent hepatitis C dual combination product Epclusa (sofosbuvir/velpatasvir) approved by the TGA late last year while also receiving a positive recommendation for PBS listing at the PBAC's November meeting.
It is likely Gilead will also take advantage of the PBAC's parallel processing, submitting its triple combination therapy to the July 2017 meeting for consideration.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 31 January 2016
Gilead has filed its latest hepatitis C triple combination therapy with the TGA with a decision likely to be made by January 2018.
The sofosbuvir/velpatasvir/voxilaprevir combination has been filed for approval as a treatment option in all six hepatitis C genotypes. If approved, it could further lengthen Gilead's lead over its rivals in claiming much of the growth in PBS revenue.
Gilead confirmed it had lodged an application with the TGA for the registration of the hepatitis C combination, with the filing following quickly after it was submitted overseas.
The triple combination was filed with the FDA in December and in Europe earlier this month. The EMA granted it accelerated review status, potentially hastening approval. Unlike Europe and the US, Australia does not provide an accelerated approval option.
In the US it has been granted breakthrough therapy designation in chronic genotype 1 patients who have previously failed an NS5A inhibitor-containing regimen.
The triple combination therapy is a once daily, single tablet 12-week regimen for genotypes 1 to 6 without cirrhosis or with compensated cirrhosis.
Global filings are being supported by data presented at the American Association for the Study of Liver Diseases annual meeting in November 2016 showing 97 per cent cure rates across all genotypes, including patients who failed on other treatments.
Gilead emerged as the big winner in PBS spending growth last year with its products generating $2.21 billion in PBS benefits (before rebates). Its leading hepatitis C products Sovaldi (sofosbuvir) and Harvoni (ledipasvir /sofosbuvir) were both PBS listed in March, considerably boosting the company's Australian revenue.
Gilead is looking to continue its local revenue growth with its most recent hepatitis C dual combination product Epclusa (sofosbuvir/velpatasvir) approved by the TGA late last year while also receiving a positive recommendation for PBS listing at the PBAC's November meeting.
It is likely Gilead will also take advantage of the PBAC's parallel processing, submitting its triple combination therapy to the July 2017 meeting for consideration.
Megan Brodie
megan.brodie@lushmedia.com.au
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