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Potential threat to Gilead's new hep C listing
Posted 8 August 2017
A new hepatitis C competitor from AbbVie could soon take the edge off the recent PBS inclusion of Gilead's pan-genotypic regimen Epclusa (sofosbuvir/velpatasvir).
If TGA approved, following a recent US green light, and if the PBAC drops a positive decision on reimbursement next week, AbbVie's Maviret (glecaprevir/pibrentasvir) may challenge Epclusa, which was PBS listed last week.
Like Epclusa, the drug is a pan-genotypic treatment but it boasts a shorter standard dosing regimen at eight weeks instead of the standard 12 for Gilead's treatment.
The four week gap between the two treatment courses has prompted analysts in the US to speculate that AbbVie's drug holds an advantage. It was approved by the FDA last week under the trade name Mavyret. Epclusa has been on the US market since June last year.
US approval may also predict the TGA's decision on whether or not to green light the drug, a decision that could come by the time the PBAC announces its recommendation on reimbursement next Friday.
The drug was passed by the US regulatory body with breakthrough and priority review designations, speeding up its pathway towards approval. It received approval in the EU last month, also going through with an accelerated assessment time.
Meanwhile Gilead's Epclusa joined the company's older regimens Sovaldi (sofosbuvir) and Harvoni (sofosbuvir and ledipasvir) as well as BMS' Hep C treatment Daklinza (daclatasvir) on the PBS as of August1.
The older treatments have seen significant declines in uptake and PBS benefits following an enormous initial splash. The new drug has been expected to help pick up some of the decline in both script numbers and spending.
The company has another triple combo Hepatitis treatment, Vosevi (sofosbuvir/velpatasvir/voxilaprevir), coming down the pipe, although as a second-line treatment it is not expected to have the same impact as Epclusa or Maviret.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 8 August 2017
A new hepatitis C competitor from AbbVie could soon take the edge off the recent PBS inclusion of Gilead's pan-genotypic regimen Epclusa (sofosbuvir/velpatasvir).
If TGA approved, following a recent US green light, and if the PBAC drops a positive decision on reimbursement next week, AbbVie's Maviret (glecaprevir/pibrentasvir) may challenge Epclusa, which was PBS listed last week.
Like Epclusa, the drug is a pan-genotypic treatment but it boasts a shorter standard dosing regimen at eight weeks instead of the standard 12 for Gilead's treatment.
The four week gap between the two treatment courses has prompted analysts in the US to speculate that AbbVie's drug holds an advantage. It was approved by the FDA last week under the trade name Mavyret. Epclusa has been on the US market since June last year.
US approval may also predict the TGA's decision on whether or not to green light the drug, a decision that could come by the time the PBAC announces its recommendation on reimbursement next Friday.
The drug was passed by the US regulatory body with breakthrough and priority review designations, speeding up its pathway towards approval. It received approval in the EU last month, also going through with an accelerated assessment time.
Meanwhile Gilead's Epclusa joined the company's older regimens Sovaldi (sofosbuvir) and Harvoni (sofosbuvir and ledipasvir) as well as BMS' Hep C treatment Daklinza (daclatasvir) on the PBS as of August1.
The older treatments have seen significant declines in uptake and PBS benefits following an enormous initial splash. The new drug has been expected to help pick up some of the decline in both script numbers and spending.
The company has another triple combo Hepatitis treatment, Vosevi (sofosbuvir/velpatasvir/voxilaprevir), coming down the pipe, although as a second-line treatment it is not expected to have the same impact as Epclusa or Maviret.
Yajun Ma
yajun.ma@lushmedia.com.au
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