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Boehringer's faldaprevir set for rapid review in Europe

More competition in emerging hepatitis C market
Boehringer Ingelheim headquarters

Boehringer Ingelheim's new hepatitis C virus (HCV) therapy faldaprevir could be on the market in the EU as early as the second half of 2014, according to the company.

The new-generation HCV protease inhibitor has been granted accelerated assessment by the European Medicines Agency (EMA) as part of a combination regimen with pegylated interferon and ribavirin.

Boehringer's marketing application is largely based on the results of the STARTverso studies, which compared faldaprevir or placebo on top of interferon and ribavirin therapy. Even in hard-to-treat patients such as those with HIV co-infection and advanced liver disease Boehringer's drug was able to achieve a sustained virologic response (SVR) in around 73 per cent of patients in 24 weeks, half the usual treatment time required for interferon and ribavirin alone.

If approved, faldaprevir will compete with current HCV protease inhibitors - namely Merck & Co's Victrelis (boceprevir) and Vertex/Johnson & Johnson's Incivo/Incivek (telaprevir) - that exploded onto the market a couple of years ago.

Incivek's sales started to slump after it was linked to progressive and potentially fatal skin reactions, which led to a boxed warning being added to its label in December 2012. Vertex was forced to announce 370 job cuts after sales fell to $85m in the third quarter from more than $250m a year earlier.

Victrelis had also been growing quickly with sales of $500m last year, but has also started to slump - falling 10 per cent to $347m in the first nine months of this year - as patients hold off for newer therapeutic options. These include Gilead Sciences' much anticipated NS5B polymerase inhibitor sofosbuvir, which has been recommended for approval in both the US and EU in recent weeks. 

Victrelis' three-times-daily dosing does not compare favourably with new-generation protease inhibitors, including faldaprevir, which are given just once-a-day, while it has other disadvantages including a tendency to cause interactions with certain IV drugs for HIV.

Other drugs emerging in the protease inhibitor class include Medivir/Johnson & Johnson's simeprevir - which was recommended for approval in the US last month - as well as Merck's vaniprevir (MK-7009), Bristol-Myers Squibb's asunaprevir and AbbVie's ABT 450.

Meanwhile, faldaprevir is also in pivotal trials as part of an interferon-free regimen alongside non-nucleoside polymerase inhibitor BI 207127 and ribavirin.

Studies have suggested that treating HCV with new all-oral regimens avoiding interferon use can increase dosing convenience and reduce side effects, and shorten treatment times while improving response rates.

Article by
Phil Taylor

28th November 2013

From: Research

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