Europe nod for Gilead HCV pill
pharmafile | January 20, 2014 | News story | Sales and Marketing | FDA, Gilead, HCV, hep C, sofosbuvir, sovaldi
Gilead Sciences’ once-daily, oral hepatitis C treatment Sovaldi has been given the green light by the European Commission, just a month after being approved in the US.
Sovaldi (sofosbuvir) is the first in a new class of medications known as nucleotide analogue polymerase inhibitors, or ‘nukes’, designed to block a specific protein that the hepatitis C virus (HCV) needs to copy itself.
Regulators have been impressed despite its expense: most patients will be treated with the $1,000-a-day drug for 12 weeks, resulting in a total list price of $84,000.
It is approved for use against chronic hepatitis C infection in adults, in combination with antiviral agents ribavirin (RBV) and pegylated interferon alpha (peg-IFN) – the current standard of care, which is not suitable for some patients.
Sovaldi has been studied in HCV genotypes 1-6, although there is limited clinical data regarding genotypes 5 and 6.
However, the brand’s efficacy has been established in patients with HCV genotypes 1 (treatment-naïve only), 2, 3 and 4, including those awaiting liver transplant at or with HCV/HIV-1 co-infection.
Analysts have forecast Sovaldi sales to reach an impressive $1.9 billion in 2014.
Gilead’s pill is the first treatment that has demonstrated safety and efficacy to treat some types of HCV infection without the need for the use of the injectable interferon treatment.
This is significant because oral HCV regimens are expected to take significant market share from existing injectable interferon treatments, which include Roche’s Pegasys and Merck’s PegIntron, which can cause debilitating side effects.
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.
Around nine million people in Europe are infected and European approval is based on five Phase III studies, in which 12 or 16 weeks of Sovaldi-based therapy was superior, or non-inferior, to RBV/peg-IFN or historical controls.
These findings were based on the proportion of patients (rates of between 50% and 90%) who had a sustained virologic response 12 weeks after completing therapy (SVR12) – the point at which they are considered cured.
Unlike many chronic diseases, hepatitis C can be cured – although many sufferers currently develop liver disease or liver cancer.
“With high cure rates across a broad range of patients and a short duration of therapy, Sovaldi is a very welcome therapeutic advance,” said Graham Foster, professor of hepatology at London’s Queen Mary University.
John Martin, Gilead chairman and chief executive, said: “We are committed to working with local governments and health systems to make sofosbuvir available in Europe as quickly as possible.”
The drug was also approved in Canada in December and has applications pending in Australia and New Zealand, Switzerland and Turkey.
Adam Hill
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