Zokinvy ((lonafarnib) achieves FDA approval
… Eiger BioPharmaceuticals Earns FDA Approval For Zokinvy …

Eiger Biopharmaceuticals: Zokinvy (lonafarnib) Earns FDA Approval

The first treatment for Hutchinson-Gilford Progeria Syndrome and some progeroid laminopathies

John G. Baresky

The U.S. Food and Drug Administration (FDA) has issued approval to Eiger BioPharmaceuticals (NASDAQ: EIGR) for Zokinvy (lonafarnib) based on an indication to reduce the risk of death due to Hutchinson-Gilford progeria syndrome and for the treatment of certain processing-deficient progeroid laminopathies in patients one year of age and older.

Zokinvy was given a Priority Review to quicken the pace of its evaluation by the FDA and speed its availability to patients and healthcare professionals.

Patients with Hutchinson-Gilford progeria syndrome and progeroid laminopathies typically have accelerated cardiovascular disease from the buildup of defective progerin or progerin-like protein in cells. Most patients typically die before reaching 15 years of age from cardiovascular issues such as heart failure, heart attack or stroke.

Before the approval of Zokinvy, the only treatment paths for Hutchinson-Gilford progeria syndrome and progeroid laminopathies patients were maintenance care and the prescribing of various therapies to treat the symptoms triggered by complications caused by the disease.

As a farnesyltransferase inhibitor, Zokinvy helps prevent the buildup of defective progerin or progerin-like protein. Available by prescription only, it is a medication that is taken orally and produced in 50mg and 75mg capsule strengths. Zokinvy is not approved for patients that have other progeroid syndromes or laminopathies.

As an oral agent, Zokinvy is far easier to prescribe and administer than injectable or infused medications. In terms of market access, Eiger should be able to readily position the product in managed care health prescription plans and government program prescription drug formularies based on its highly specific FDA indication. As the first and only therapy with its indication, Zokinvy has no competitors.

Zokinvy was given Orphan Drug status that provides incentives to assist and encourage the development of drugs for rare diseases and Breakthrough Therapy Designation. Eiger BioPharmaceuticals also received a rare pediatric disease priority review voucher which promotes the development of new advanced therapies and biopharmaceuticals to prevent and treat rare diseases in children.

As a late-stage biopharmaceutical enterprise focused on the development and commercialization of first-in-class therapies for serious rare and ultra-rare diseases, Eiger is a clinically-centered organization with a business outlook. Its research and development product pipeline features:

  • Lonafarnib/Ritonavir for Hepatitis Delta Virus (HDV): Phase III
  • Peginterferon Lambda for Hepatitis Delta Virus (HDV): Phase III ready
  • Avexitide for post-bariatric hypoglycemia (PBH): Phase III ready
  • Avexitide for congenital hyperinsulinism (CHI): Phase II

Congratulations are in order for Eiger BioPharmaceuticals as Zokinvy is clearly addressing a challenging and unmet medical need. Pediatricians, medical geneticists, pediatric cardiologists and other healthcare professionals that diagnose and treat patients afflicted with Hutchinson-Gilford Progeria Syndrome and progeroid laminopathies now have a viable treatment option to help them. Founded in 2000, Eiger BioPharmaceuticals is based in Palo Alto, California.

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