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

As a new therapy with no equal, Zokinvy is a go-to option where none existed before

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.

Zokinvy is a novel, highly specialized therapy

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.

Eiger’s market access strategy will be compact due to Zokinvy’s narrow indication and highly specialized patient care segment

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.

The FDA recognizes the significance Zokinvy has for medical professionals and the patients they care for

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.

Eiger BioPharmaceuticals is dedicated to the exploration and creation of new complex therapies to treat uncommon and challenging diseases

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:

  • 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

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