Eiger BioPharmaceuticals Inc. said the U.S. Food and Drug Administration has granted breakthrough therapy designation to its Hepatitis delta virus medicine lonafarnib.
Hepatitis delta virus, or HDV, causes an infection in patients who are already harboring the Hepatitis B virus and can lead to more severe liver disease. HDV infection, which affects about 15 million to 20 million people worldwide, currently does not have an approved treatment, Eiger said in a Dec. 17 press release. The infection is considered one of the most severe forms of viral hepatitis in humans.
The FDA's designation is based on data from phase 2 clinical trials of lonafarnib in HDV-infected patients, which showed that the drug improved liver condition and suppressed viral loads. Palo Alto, Calif.-based Eiger is beginning a global phase 3 study in HDV to develop two separate, lonafarnib-based treatment regimens.
Lonafarnib, a drug that modifies proteins, received orphan drug designation by the U.S. FDA and European Medicines Agency in 2014. The drug has also received rare pediatric disease status from the FDA to treat progeria and progeroid laminopathies, which cause accelerated aging in children.
According to the company, a new drug application for lonafarnib is expected in 2019. The FDA's breakthrough therapy designation will accelerate the development and review of the drug.
Eiger licensed lonafarnib from Merck & Co. Inc. and will lead regulatory development, commercialization and distribution of the drug.