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Versartis GHD Treatment Gets Orphan Status

Monthly rhGH currently in safety/efficacy trials for pediatric patients

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Versartis, Inc., has received Orphan Drug designation from the FDA for its product candidate VRS-317 for the treatment of growth hormone deficiency (GHD) at once-a-month dosing. The company previously received a similar designation from the European Commission for VRS-317. VRS-317, the company’s proprietary long-acting form of recombinant human growth hormone (rhGH), is currently being investigated for safety and efficacy in pediatric GHD patients. At the present time all marketed growth hormone treatments require daily injections.

The Orphan Drug Act was enacted to encourage the development of drugs for the diagnosis, prevention and treatment of medical conditions affecting fewer than 200,000 people in the United States. Orphan designation grants potential U.S. market exclusivity to a drug for the treatment of a specified condition for a period of seven years following FDA marketing approval. In addition, potential benefits of orphan designation include development grants, tax credits related to clinical trial expenses, protocol development assistance and exemption from FDA user fees.

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