EATG » FDA grants orphan drug designation to Lambda for HDV

FDA grants orphan drug designation to Lambda for HDV

FDA granted orphan drug designation to Eiger BioPharmaceuticals for its pegylated interferon lambda 1a, known as Lambda, to treat chronic hepatitis delta virus infection, according to a press release.

Lambda, a top, late-stage type III interferon, stimulates immune responses that help develop host protection during viral infections by targeting specific receptors, according to the press release. These specific type III interferon receptors are expressed on hepatocytes with limited expression on hematopoietic and central nervous system cells, which can decrease off-target effects and increase tolerability of Lambda, per the release. Further, Lambda does not use the IFN alfa receptor, which targets type 1 interferon receptors, but signaling through either the IFN Lambda or IFN alfa receptor complexes causes the activation of the same Jak-STAT signal transduction cascade.

Researchers have administered this potential HDV treatment in hepatitis B virus/HCV clinical trials involving more than 3,000 patients, but it has not received approval for any indication, per the press release.

The designation of this potential HDV therapy correlates with the FDA Office of Orphan Products Development’s mission to advance the development of products and therapies that show promise for diagnosing and treating rare diseases, per the release.

News categories: Hepatitis, EMA/FDA