News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

US FDA Grants Orphan Drug Designation To Versartis, Inc.' Treatment For Growth Hormone Deficiency



12/18/2013 10:15:27 AM

free biotech news Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

REDWOOD CITY, CA--(Marketwired - 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."

About Versartis
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.


Contacts:
Corporate
Joshua Brumm
Chief Financial Officer
Ph: 650 963-8582
Email: Email Contact

Media
Debra Bannister
Corporate Communications
Ph: 530 676-7373
Email: Email Contact



Help employers find you! Check out all the jobs and post your resume.

Read at BioSpace.com


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES