We've updated our Privacy Policy to make it clearer how we use your personal data.

We use cookies to provide you with a better experience. You can read our Cookie Policy here.

Advertisement
Santhera Receives FDA Fast Track Designation for Raxone®/Catena®
News

Santhera Receives FDA Fast Track Designation for Raxone®/Catena®

Santhera Receives FDA Fast Track Designation for Raxone®/Catena®
News

Santhera Receives FDA Fast Track Designation for Raxone®/Catena®

Read time:
 

Want a FREE PDF version of This News Story?

Complete the form below and we will email you a PDF version of "Santhera Receives FDA Fast Track Designation for Raxone®/Catena®"

First Name*
Last Name*
Email Address*
Country*
Company Type*
Job Function*
Would you like to receive further email communication from Technology Networks?

Technology Networks Ltd. needs the contact information you provide to us to contact you about our products and services. You may unsubscribe from these communications at any time. For information on how to unsubscribe, as well as our privacy practices and commitment to protecting your privacy, check out our Privacy Policy

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."

Advertisement