Yeliva receives FDA orphan drug status for cholangiocarcinoma

Release Date: 03-Apr-2017

US Food and Drug Administration has granted orphan drug designation to Yeliva a first-in-class, orally administered, sphingosine kinase-2 selective inhibitor with anticancer and anti-inflammatory activities, for the effective treatment of cholangiocarcinoma. The drug is developed by RedHill Biopharma. The investigation suggested that the drug is well endured and can be safely administered to patients suffering from the disease. The action of mechanism for Yeliva includes circulation in the patient’s body to create a therapeutic activity.
Presently, the company is planning to investigate the drug under Phase1b clinical study as a radio protectant for the prevention of mucositis in patients with head and neck cancer undergoing therapeutic radiotherapy, as well as a phase 2 study of the drug to treat patients with moderate to severe ulcerative colitis.
FDA grants orphan drug designation to those products like drugs and therapies that treat rare diseases. The administration defines rare diseases as those affecting fewer than 200,000 people in United States. Orphan drug designation provides certain financial benefits such as incentives to the developing company. These benefits include market exclusivity for the marketing application, if regulatory approval is received for the designated indication, potential tax credits for certain activities and waiver of certain administrative fees.
“Global Orphan Drug Clinical Pipeline Insight” reports by kuick research gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.
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