Genentech’s Gantenerumab Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Alzheimer’s Disease

October 11, 2021 Auto Bot alzheimer's disease, Breakthrough Therapy Designation, FDA, Genentech, regulatory 0

Shots:

  • The designation is based on the data from an ongoing SCarlet RoAD, Marguerite RoAD OLE trials along with other studies evaluating gantenerumab (anti-amyloid beta Ab) in patients with AD, demonstrated a reduction in brain amyloid plaque
  • The studies have been included in the optimized design of two ongoing P-III trials, GRADUATE 1 & 2 that evaluates the effects, safety & efficacy of gantenerumab (1020mg) vs PBO in 2,000 patients with early AD across ~350 study centers in 30+ countries globally. The results are expected in H2’22
  • The company continues to explore multiple approaches and molecules for the treatment of AD & support clinicians to monitor disease progression

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

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