The U.S. Food and Drug Administration granted a breakthrough therapy designation for Eiger BioPharmaceuticals Inc.'s peginterferon lambda to treat hepatitis delta virus infection.
Hepatitis delta virus occurs only as a co-infection in people infected with hepatitis B and has no approved therapy. The disease leads to more severe liver disease than hepatitis B alone and is associated with accelerated liver fibrosis, liver cancer and liver failure.
The Palo Alto, Calif.-based biopharmaceutical company is developing peginterferon lambda as a monotherapy for infected patients. Lambda is a type III interferon, which causes nearby cells to heighten immune responses critical to developing host protection during viral infections.
Medicines classified by the FDA as breakthrough therapy are those intended for serious or life-threatening conditions and receive accelerated development and review.
The FDA designation for peginterferon lambda is based on data from a phase 2 monotherapy study, called Limt Lambda, of 33 patients infected with hepatitis delta virus. Peginterferon lambda already has an orphan drug designation from both the FDA and the European Medicines Agency.
Previously, the FDA granted breakthrough therapy designation to Eiger's Lonafarnib to treat hepatitis delta virus infection.
