FDA grants Fast Track designation for the Phase III clinical investigation of arimoclomol as a treatment of Niemann-Pick disease type C
Copenhagen, Denmark, June 27, 2016; Orphazyme ApS announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of arimoclomol intended for the treatment of Niemann-Pick disease type C. The FDA’s Fast Track program is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
"The Fast Track designation is really good news for everyone involved in the AIDNPC trial, not least the sufferers of Niemann-Pick disease type C who deserve that every effort is made to expedite development of promising new therapies”", says Orphazyme ApS CEO Anders Hinsby.
The Fast Track designation comes three weeks after the FDA gave a positive review of the AIDNPC Investigational New Drug (IND) application, allowing the trial to proceed at full speed. The opening of at least two clinical sites in the US is now in preparation. Orphazyme expects to announce the participating clinical sites in the near future.
Anders M. Hinsby, CEO at Orphazyme ApS