FDA approval for Eiger's Zokinvy

Shares of US rare diseases drug developer Eiger BioPharmaceuticals (Nasdaq: EIGR) rose more than 12% to $11.25 in after-hours trading on Friday, after it revealed that the US Food and Drug Administration has approved Zokinvy (lonafarnib) for the treatment of Hutchinson-Gilford Progeria syndrome (HGPS or Progeria) and processing-deficient Progeroid laminopathies (PL).

Zokinvy is the subject of a licensing deal with US pharma giant Merck & Co (NYSE: MRK) that provides Eiger with commercial and distribution rights to lonafarnib across the licensed and approved indications in the future. Merck will not receive any milestone payments for the development of Zokinvy to treat Progeria and has waived royalty obligations from Eiger for a specified quantity of lonafarnib.

Progeria and Progeroid laminopathies are separate and distinct ultra-rare, genetic, premature aging diseases that accelerate mortality in young patients. Disease manifestations include growth failure, loss of body fat and hair, aged-looking skin, stiffness of joints, hip dislocation, generalized atherosclerosis, cardiovascular disease and stroke. Untreated children with Progeria die of heart disease at an average age of 14.5 years. There are 20 children and young adults with Progeria and PL identified and followed in the USA.