The U.S Food and Drug Administration have granted orphan drug designation to ABBV-006, developed by AbbVie pharmaceuticals for the treatment of Crohn’s Disease in pediatric patients. The drug is currently in its investigational phase, IL-23 inhibitor, rizankumab, (ABBV-066; formerly BI 655066).
In March, 206, AbbVie and Boehringer Ingelheim collaborated for an agreement stating that the former is responsible for the commercialization and development of Rizankumab globally. AbbVie acquired all rights to rizankumab under this collaboration agreement. Currently, rizxankumab is also under investigation for its use in the treatment of immunological disorders such as psoriasis, psoriatic arthritis and asthma.
Orphan Drug designation is granted to those medications or therapy that are rare, more specifically, affect less than 200,000 patients in the country. These rare diseases are incurable and severe in nature and may cause death. To fulfill the need of treat options for individuals, FDA grants orphan drug designation to drugs which are investigated to be helpful in the treatment of such rare diseases. Orphan drug status is a package of several financial benefits for the drugs and its manufacturers such as certain tax credits and exemption from paying prescription drug user fees normally required from companies submitting products for approval.
For Orphan Drug Clinical Insight Reports Contact: neeraj@kuickresearch.com
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