US Food and Drug Administration has granted orphan drug designation to an oral liquid suspension of celecoxib for the treatment of children suffering from pediatric juvenile idiopathic arthritis. The liquid suspension is developed and formulated by a clinical stage biopharmaceutical company, NuBioPharma, LLC. Nu-Celecoxib has been developed within flavors for children enabling measurement of precise doses that can easily be administered.
Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis in children under the age of 17. JIA is a chronic disease causing illness, flu-like symptoms, and serious inflammation in eyes, rashes, joint pain, swelling and stiffness. Prevalence of JIA is recorded to be 141,300 patients in United States.
FDA's Orphan Drug Designation program provides certain incentives for companies developing therapeutics to treat rare diseases or conditions, defined as those affecting less than 200,000 individuals in the U.S. A drug candidate and its sponsor must meet several key criteria in order to qualify for, and obtain, orphan drug status. Once a drug has received orphan drug designation, the developer qualifies for a range of benefits, including federal grants, tax credits, reduction in certain regulatory fees, and the potential for seven years of market exclusivity for the drug following FDA marketing approval.
For Orphan Drug Clinical Insight Reports Contact: neeraj@kuickresearch.com
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