Potential DMD Treatment, Raxone, Designated ‘Orphan Drug’ by Australian Regulators

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has granted  Santhera Pharmaceuticals’ lead product Raxone (idebenone) orphan drug designation for the treatment of Duchenne muscular dystrophy (DMD). Raxone (sold in some markets under the trade name Catena) has already received a similar designation from European, Swiss, and…

Drug to Possibly Treat DMD, Idebenone (Raxone), Under CHMP Review in Europe

Santhera Pharmaceuticals reports that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for its drug Raxone (idebenone;  U.S. brand name, Catena) as a treatment for Duchenne muscular dystrophy (DMD) in patients with respiratory function decline and who are not under glucocorticoid therapy. The EMA validation confirms…

Duchenne MD Therapy, Raxone, to Be Submitted for NDA in US and MAA in Europe

Santhera Pharmaceuticals announced updates on regulatory filings for Raxone (idebenone), saying it plans to submit comprehensive briefing material and a meeting request to the Food and Drug Administration (FDA) to discuss filing a New Drug Application (NDA) for the treatment of Duchenne Muscular Dystrophy (DMD) patients who are not taking concomitant…

Santhera Receives FDA Fast Track Designation For Raxone®/Catena® To Treat Duchenne Muscular Dystrophy

Santhera Pharmaceuticals recently announced it received Fast Track designation from the United Stated Food and Drug Administration (FDA)  for its Raxone®/Catena® (idebenone) to address treatment for Duchenne Muscular Dystrophy (DMD). Through the FDA’s Fast Track program, both the development and review of the drug are facilitated, since the has the potential to treat a severe condition, fill unmet medical…