Santhera Receives FDA Fast Track Designation for Raxone®/Catena®
News Apr 10, 2015
Santhera Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Santhera's Raxone®/Catena® (idebenone) for the treatment of Duchenne Muscular Dystrophy (DMD).
FDA's Fast Track program facilitates the development and review of important drugs intended to treat serious conditions and fill an unmet medical need for the purpose of getting them to the patient earlier.
Santhera previously announced that the Phase III trial (DELOS) in DMD met its primary endpoint and demonstrated that Raxone/Catena delayed the loss of respiratory function.
"We are very pleased that the FDA has granted Fast Track designation for Raxone/Catena, which further underscores the unmet medical need for effective treatments for patients with DMD," commented Thomas Meier, PhD, CEO of Santhera. "On the basis of the positive data from our Phase III trial with Raxone/Catena in DMD, we have started to prepare a New Drug Application and plan to meet with the FDA in the coming weeks to discuss our NDA dossier in a pre-NDA meeting."
Study Extends Potential of Personalized Cell-based ImmunotherapiesNews
New methods developed for the study could be applied to devise personalized, cell-based immunotherapies for epithelial ovarian cancer or other types of tumorsREAD MORE
Hope for Hot Flushes: New Class of Menopause Drugs Reduces SeverityNews
A new class of experimental drugs reduces hot flushes in menopausal women by almost three-quarters in just three days. The new analysis, published in the journal Menopause, also revealed sleep and concentration significantly improved in the three-day window.
Domainex Appoints Dr Bodo Spori as Head of Business Development for EuropeNews
Domainex Ltd, a privately-owned drug discovery services company, is pleased to announce the appointment of Dr Bodo Spori as Head of Business Development for Europe.READ MORE
Comments | 0 ADD COMMENT
World Congress on Clinical And Medical Microbiology
Sep 10 - Sep 11, 2018