Gilead’s Harvoni Wins FDA Okay | Chemical & Engineering News
Volume 92 Issue 42 | p. 17 | Concentrates
Issue Date: October 20, 2014

Gilead’s Harvoni Wins FDA Okay

Department: Business
Keywords: pharmaceuticals, biotech, HCV, antivirals, drug prices
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Harvoni
Credit: Gilead
Photo of a Harvoni capsule.
 
Harvoni
Credit: Gilead

Gilead Sciences has received FDA approval for the hepatitis C virus (HCV) treatment Harvoni, a single pill that combines the already-approved antiviral sofosbuvir—marketed as Sovaldi—and a new antiviral, ledipasvir. Approved in December, Sovaldi gained notoriety as the most successful drug launch in history, racking up $5.8 billion in sales in the first half of this year. It has also come under scrutiny for its cost: $1,000 per pill. Harvoni will be $1,125 per tablet, putting a $94,500 price tag on a typical 12-week regimen of the drug. Gilead’s potential windfall from Harvoni could be stunted by state Medicaid plans, many of which are already putting limits on who can have Sovaldi.

 
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