Eiger gets 'Breakthrough' status for HDV drug

17 December 2018

California-based Eiger BioPharmaceuticals (Nasdaq: EIGR) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lonafarnib for the treatment of hepatitis delta virus (HDV) infection.

This is the most severe form of human viral hepatitis and it has no approved treatment. Lonafarnib is supported by Phase II data and it is in Phase III development with a single, pivotal trial.

Lonafarnib has been granted Orphan Drug designation by the FDA and European Medicines Agency, and Fast Track and now Breakthrough designation by the FDA. It is licensed from US pharma giant Merck & Co (NYSE: MRK).

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