Boehringer stops development of faldaprevir for HCV

Boehringer Ingelheim Pharmaceuticals has withdrawn all marketing applications for its hepatitis C virus protease inhibitor faldaprevir and will discontinue developing the drug because of other new treatment options, a company press release said.

Development of faldaprevir has been stopped due to the growing market of successful drugs to treat patients with HCV and those that are still pending. Boehringer said there is “no longer an unmet medical need” for the regimen. In addition, according to the release, there are several new oral treatment options available for patients that will be approved later this year.

Faldaprevir was being tested in combinations with pegylated interferon and ribavirin, and in interferon-free regimens with other antiviral agents. It had shown potential in treating patients coinfected with HCV and HIV in the STARTVerso 4 trial, where at 12 weeks, 88% of patients had HCV RNA levels below the limit of quantification, and 84% of patients had undetectable levels.

A new drug application for faldaprevir was already accepted for filing by the FDA and pending approval. Faldaprevir also had a marketing application in Europe that was granted accelerated assessment from the European Medicines Agency in late 2013.