Eiger BioPharmaceuticals Inc. has been granted a priority medicine designation for its hepatitis delta virus medicine by the European Medicines Agency, a day after receiving a similar status from U.S. regulators.
Hepatitis delta virus, or HDV, is considered to be one of the most severe forms of viral hepatitis in humans and occurs as a co-infection in individuals harboring hepatitis B virus. HDV leads to more severe liver disease than hepatitis B virus alone and is associated with accelerated liver fibrosis, liver cancer and liver failure. The infection affects about 15 million to 20 million people worldwide, said Eiger in its Dec. 18 press release.
The EMA's designation is awarded to medicines that show potential to benefit patients with unmet medical needs and provides for their expedited review and approval process. Lonafarnib received the U.S. Food and Drug Administration's breakthrough therapy designation Dec. 17 also to treat patients with HDV.
The Palo Alto, Calif.-based biopharmaceutical company said the EMA designation was based on data from a phase 2 trial that showed an improvement in liver condition and virologic response in untreated HDV patients.
The company said it has begun a global trial with the potential to bring two separate, lonafarnib-based treatment options to HDV patients.
Eiger licensed lonafarnib from Merck & Co. Inc. to lead the regulatory development, commercialization and distribution of the drug.