Eiger Biopharma announced it has initiated submission of a New Drug Application (NDA) to the FDA under the Rolling Review Process. The company is seeking approval for lonafarnib for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies. The Rolling Review NDA process allows for portions of an NDA to be submitted and reviewed by the FDA on an ongoing basis. Eiger plans to complete the NDA rolling submission in first quarter of 2020.
Lonafarnib has been dosed in over 80 children with Progeria at Boston Children’s Hospital in Phase 1/2 and Phase 2 studies funded by The Progeria Research Foundation. In patients with HGPS, lonafarnib monotherapy was associated with a lower mortality rate after 2.2 years of follow-up compared with no treatment (3.7% vs 33.3%, respectively) with a hazard ratio of 0.12 or a reduction in risk of mortality of 88%.
Lonafarnib has been granted Orphan Drug Designation for Progeria and Progeroid Laminopathies by the FDA and EMA and Breakthrough Therapy Designation and Rare Pediatric Disease Designation by the FDA.
About ProgeriaProgeria, also known as Hutchinson‐Gilfor...
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