Biogen to Initiate P-II/III DEVOTE Study Evaluating the Higher Doses of Spinraza (nusinersen) for Spinal Muscular Atrophy

 Biogen to Initiate P-II/III DEVOTE Study Evaluating the Higher Doses of Spinraza (nusinersen) for Spinal Muscular Atrophy

Biogen Exercises Exclusive Worldwide Option to Develop & Commercialize Ionis’s BIIB067 (IONIS-SOD1RX) for Amyotrophic Lateral Sclerosis (ALS)

Shots:

  • The P-II/III DEVOTE study will evaluate the higher doses of Spinraza in 126 patients with SMA of all ages. The three-part study will include an open-label safety study followed by an open-label treatment period
  • The study will compare two loading doses of Spinraza (50mg) 15days apart followed by a maintenance dose of 28 mg every 4mos. with FDA approved dose of Spinraza (4 loading doses with 12mg maintenance dose every 4mos.). The third part of the study will determine the safe & efficient transition of patients from the currently approved dose to the higher dose being evaluated in the study
  • Spinraza is the first therapy to be approved for SMA in infants, children & adults, demonstrated an improvement in or stabilization of motor function in patients aged ≤21yrs. in a SHINE study for nearly 6yrs.

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

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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