Breaking News, Trials & Filings

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 h...

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