Resunab by Corbus Pharma receives Orphan drug status by EC

Release Date: 01-Dec-2016

Corbus Pharmaceutical Holdings Inc. announces that its leading asset has been granted orphan drug designation by European Commission for the treatment of patients with Cystic Fibrosis. Resunab is the synthetic oral endocannabinoid-mimetic drug.


The pharmaceutical firm previously announced that the drug has been granted orphan drug status and fast track status for the treatment of systemic sclerosis by the US food and Drug Association (FDA). Currently, the drug is undergoing three clinical studies in phase 2 trials for Cystic Fibrosis, Systemic Sclerosis and dermatomyositis. Furthermore, the drug is expected to undergo clinical study for treatment of systemic lupus erythematosus in the first quarter of 2017.


The European Commission grants orphan medicinal product status to provide incentives to develop medicinal products to treat, prevent or diagnose diseases or conditions that affect no more than five in 10,000 persons in the EU. The orphan medicinal product status designation provides the company and its drug with certain benefits and incentives in the EU, including a period of market exclusivity.



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