US FDA Grants Orphan Drug Designation to Versartis’ Treatment for Growth Hormone Deficiency
Redwood City, CA – December 18, 2013 – Versartis, Inc., an endocrine-focused biopharmaceutical company, has received US Food and Drug Administration (FDA) orphan drug designation 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 by the European Commission for VRS-317, the company’s proprietary long-acting form of recombinant human growth hormone (rhGH). VRS-317 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 US 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 US 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.
“We are very pleased to receive orphan drug designation from the US FDA, as we advance our VRS-317 program through the ongoing Phase 2 clinical trial,” stated Versartis Chief Executive Officer Jeffrey L. Cleland, PhD. “We are pursuing a global development plan for VRS-317, and this designation – by both the US and European agencies – aids our efforts and further indicates the importance of this potential new treatment for patients with growth hormone deficiency.”
Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing VRS-317, a novel long-acting form of human growth hormone, for the treatment of growth hormone deficiency. The company is currently conducting a Phase 2 clinical trial of VRS-317 in children with growth hormone deficiency. Further information on Versartis can be found at www.versartis.com.