Ipsen Biopharmaceuticals: New FDA Orphan Drug Designation For Huntington’s Disease
Ipsen Biopharmaceuticals receives FDA ODD for Huntington’s Disease on March 16th. Currently, the company is recruiting for a Phase II clinical trial (“Study exploring safety, pharmacokinetic and pharmacodynamics of BN82451 in Male Huntington’s Disease Patients”; NCT02231580) of BN8245B versus placebo after oral administration twice daily for 28 days in patients with HD.
FDA ODD Database Record For Ipsen Biopharmaceuticals
|Generic Name:||Phenol, 4-[2-(aminomethyl)-4-thiazolyl]-2,6-bis (1,1-dimethyethyl) monohydrochloride|
|Orphan Designation:||Huntington’s Disease|
|Orphan Designation Status:||Designated|
|FDA Orphan Approval Status:||Not FDA Approved for Orphan Indication|
|Sponsor:||Ipsen Biopharmaceuticals, Inc. 106 Allen Road 3rd Floor Basking Ridge, NJ 07920|