Eiger to seek FDA approval of progeria therapy

Eiger BioPharmaceuticals Inc. (NASDAQ:EIGR) intends to submit an NDA to FDA next year for lonafarnib to treat Hutchinson-Gilford progeria syndrome, an ultra-rare premature aging disease. The company said the NDA will be based on existing data showing a survival benefit in progeria patients, and Eiger does not expect to conduct additional clinical efficacy studies prior to the submission.

Lonafarnib, a farnesyl transferase inhibitor, has Orphan Drug designation in the U.S. to treat progeria, for which there are no approved therapies. Eiger holds the compound's rights in progeria from Merck & Co. Inc. (NYSE:MRK) under a deal expanded in May. The biotech is supplying lonafarnib for clinical trials, and is developing the candidate via a collaboration with the not-for-profit Progeria Research Foundation (PRF)...