Project ALS’ Prosetin Receives the US FDA’s Orphan Drug Designation for Amyotrophic Lateral Sclerosis

 Project ALS’ Prosetin Receives the US FDA’s Orphan Drug Designation for Amyotrophic Lateral Sclerosis

Project ALS’ Prosetin Receives the US FDA’s Orphan Drug Designation for Amyotrophic Lateral Sclerosis

Shots:

  • The US FDA has granted ODD to Prosetin for the treatment of ALS. ODD provides incentives for the development of drugs, biologics, and devices for diseases affecting 200,000 or fewer Americans
  • By obtaining ODD, Prosetin is now eligible for benefits including up to 7yrs. of marketing exclusivity if it receives regulatory approval, exemption from FDA user fees, FDA assistance in clinical trial design, and tax credits for clinical research
  • Prosetin is an oral, brain penetrant MAP4 kinase inhibitor, developed at Columbia University for the treatment of ALS

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Twitter

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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