Verantis Gets Orphan Drug Status from US FDA for VS-01

Verantis has been awarded the status of Orphan Drug for its VS-01 product. The product will be used for treating Hyperammonemia in Inborn Errors of Metabolism. The company develops therapeutics and diagnostic products for liver diseases. It is developing new treatment methods for the diseases associated with liver and pediatric diseases. The company today announced the company has received an Orphan Drug status from the US food and drug administration for its product VS-01. The company has developed VS-01 for treating hyperammonemia (HA) in IEM.

The company is in process of raising more funds for advancing the development of VS-01 for making it accessible in the markets for clinical practice. The designation awarded for the products is extremely significant and proves its scientific rationale for VS-01. This designation will thus boost its development for treating multiple genetic disorders.

The VS-01 is expected to play a critical role in removing the life-threatening build-up of ammonia. The US FDA has given the Orphan Drug status for VS-01 two main indication namely hyperammonemia in EHM and Acute-on-chronic Liver Failure (ACLF). It status will boost the company’s clinical development plan and contribute majorly in addressing the increasing burden of rare liver and metabolic diseases.

The US FDA ODD is a program designed for sponsors that are developing drugs and diagnostics products for addressing rare diseases and medical conditions. The program aims to provide incentives to these sponsors, give them tax credits (eligible sponsors) for clinical trial costs. Also, the eligible sponsors are waivers and are considered for marketing their products exclusively for seven years.