Minoryx therapeutics announces orphan drug designation for MIN-102
Release Date: 27-Mar-2017
Minoryx Theapeutics, a leading drug development company focused on developing orphan drugs for rare diseases recently, announced that US Food and Drug Administration (FDA) has granted orphan drug designation to its leading product candidate, MIN-102 for the treatment of patients with life threatening CNS disease with high unmet medical need. MIN-102 contains superior profile with selective PPAR gamma agonist for diseases linked with central nervous system. MIN-102 targets X-linked adrenoleukodystrophy (X-ALD), a rare and chronically debilitating life threatening neurodegenerative disease. Additionally, the drug has been previously awarded with orphan drug designation by European Medicine Agency (EMA).
FDA and EMA 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.
