Gilead’s $1,000 per day Hep C drug approved
pharmafile | December 9, 2013 | News story | Sales and Marketing | FDA, Gilead, hepc, sofosbuvir, sovaldi
Gilead’s Sovaldi has gained FDA approval as a potential cure for hepatitis C after the US regulator sped up its review time for the ‘breakthrough’ pill.
Sovaldi (sofosbuvir) is now licensed to treat chronic hepatitis C virus (HCV) infection in the US. According to Gilead most patients will be treated with the $1,000-a-day drug for 12 weeks, resulting in a total list price of $84,000.
Sovaldi is the first in a new class of medications known as nucleotide analogue inhibitors, or ‘nukes’, designed to block a specific protein that the hepatitis C virus needs to copy itself.
Analysts have forecast Sovaldi sales to reach an impressive $1.9 billion next year, according to BMO Capital Markets. The drug has also been given a positive CHMP recommendation and could be approved in Europe by early 2014, which will help increase revenue.
Gilead’s pill is the first treatment that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for the use of the injectable interferon treatment.
The drug can be used in combination with ribavirin, an older antiviral pill, for patients with genotypes 2 and 3 infections, which account for about 28% of US patients infected with the virus.
But for patients with genotype 1 – which accounts for about 70% of US infections – the drug must still be used with both interferon and ribavirin, although it can be considered for use in patients with genotype 1 infections who cannot use interferon.
Patients with the much less common genotype 4 infections will also be treated with a three-drug combination.
“[This] approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Edward Cox, director of the office of antimicrobial products at the FDA.
Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection – in late November the US regulator also approved Janssen’s Olysio (simeprevir).
In 2011 the FDA approved two other pills for hepatitis C, both in the protease inhibitor class: Merck’s Victrelis (boceprevir) and Vertex Pharmaceuticals’ Incivek (telaprevir).
It is a potentially lucrative area for manufacturers: the market for hepatitis C drugs could rise to being worth more than $100 billion over the next decade, according to Bloomberg Industries.
The viral disease – estimated to affect over three million Americans – causes inflammation of the liver and can lead to that organ’s failure. The virus can go on to cause bleeding, jaundice, fluid accumulation in the abdomen, infections or even liver cancer.
Ben Adams
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