AbbVie hep C treatment fast-tracked
pharmafile | June 18, 2014 | News story | Research and Development, Sales and Marketing | AbbVie, Abbott, EMA, EU, Gilead, HCV, hep C, sovaldi
The European regulator is to fast-track AbbVie’s oral, interferon-free treatment for adults with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.
The regimen is a fixed-dose combination of ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without ribavirin (RBV).
The manufacturer’s applications, submitted last month, have been validated and are under accelerated assessment by the European Medicines Agency (EMA). Last week, the US Food and Drug Administration gave the same applications priority review status.
AbbVie’s belief is that combining three different mechanisms of action interrupts the HCV replication process, which should in turn improve sustained virologic response rates across different patient populations.
This includes those who would typically not respond well – such as sufferers in whom interferon-based therapy has already failed or patients with advanced liver fibrosis or cirrhosis.
The company is hoping that the new regimen could be marketed in the European Union as early as the first quarter of 2015 now that the EMA’s review process has formally begun.
Accelerated assessment status is granted to “new medicines of major public health interest”. AbbVie’s submission is supported by data including six Phase III studies of more than 2,300 GT1 patients in over 25 countries.
ABT-450 was discovered as part of the collaboration between AbbVie and Enanta Pharmaceuticals to find HCV protease inhibitors and regimens that include this class of drugs.
The compound is being developed by AbbVie for use in combination with other investigational medicines for the treatment of hepatitis C.
It is a potentially lucrative area for manufacturers: the market for hepatitis C drugs could rise to more than $100 billion over the next decade, according to Bloomberg Industries.
Around 170 million people worldwide have HCV, a virus that infects the liver and can lead to cirrhosis and liver cancer, with nine million estimated to be living with the disease in the European Union.
Gilead’s once-daily, oral hepatitis C treatment Sovaldi (sofosbuvir) has been marked out by analysts as a market leader, with annual sales of $9 billion or more predicted.
Adam Hill
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