Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

  • Gantenerumab is an investigational antibody in Phase III development for early Alzheimer’s disease (AD)
  • Gantenerumab is the first and only anti-amyloid antibody being investigated for subcutaneous administration in late-stage trials for the treatment of AD
  • Ongoing Phase III GRADUATE programme with gantenerumab is anticipated to deliver a comprehensive data set with expected readout in the second half of 2022

Roche (SIX RO, ROG; OTCQX RHHBY) now posted that gantenerumab, ananti-amyloid beta antibody developed for subcutaneous administration, has been granted Improvement Rectifier Designation by theU.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s fever ( Notice). This designation is predicated on data showing that gantenerumab significantly reduced brain amyloid pillar, a pathological hallmark of Notice, in the ongoing SCarlet RoAD and Marguerite RoAD open- tag extension trials, as well as other studies. Learnedness from these studies have been incorporated into the optimised design of two ongoing parallel, global, placebo- controlled and randomised Phase III trials, GRADUATE 1 and 2. The key trials are setting gantenerumab in fresh than parties for fresh than two spans and are awaited to be completed in the substitute half of 2022.

“ For other than a decade, we ’ve been committed to advancing the wisdom of Alzheimer’s as well as our investigational specific gantenerumab, and we look forward to delivering a comprehensive and robust data set that furthers our united understanding of this ruinous trouble,” said Levi Garraway,M.D.,Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “ This Refinement Therapeutic Designation reinforces our confidence in gantenerumab, which would be the first subcutaneous specific for the treatment of Alzheimer’s trouble with the prospect for at- home administration.”
Improvement Rectifier Designation is designed to accelerate the development and review of pharmaceuticals intended to treat serious or life- menacing conditions with prelusive testimonial that indicates they may demonstrate a substantial enhancement over available rectifiers that have entered full FDA imprimatur. This designation for gantenerumab marks the 39th Improvement Rectifier Designation for Roche’s portfolio of pharmaceuticals.

Notice is a progressive, fatal fever of the brain characterised by a decline in memory, language and other thinking moxie, as well as changes in mood and conduct. Consanguineous changes in the brain are believed to start decades before clinical symptoms of Notice run putative. Alzheimer’s is the most common form of madness, which presently affects farther than 55 million people worldwide, and is projected to reach 78 million by 2030. An enormous and growing public health challenge, it’s prognosticated to cost the global providence a conglomerative$ 20 trillion over the following decade, or US$2.8 trillion per space by 2030. Much 10 million people widely are diagnosed with Notice each space. Given the medical and societal difficulties of Notice, several tools and treatment options will likely be needed to meet the multiple and distinguishable necessities of people living with the fever.

About gantenerumab and its clinical program
Gantenerumab is an investigational IgG1 antibody designed to bind to aggregated forms of beta-amyloid and remove brain amyloid plaques, a pathological hallmark of Alzheimer’s disease (AD). Gantenerumab significantly lowered amyloid plaque in patients with sporadic AD in the SCarlet RoAD and Marguerite RoAD open-label extension studies, and with dominantly inherited AD in the DIAN-TU-001 study. Learnings from these studies have been incorporated into the optimised design of two ongoing parallel, global, placebo-controlled and randomised Phase III trials, GRADUATE 1 and 2.

The pivotal GRADUATE trials are investigating the effect of gantenerumab on amyloid load and downstream biomarkers of disease progression as well as the safety and efficacy of gantenerumab in people with early (prodromal-to-mild) AD. The studies include more than 2,000 patients treated for more than two years in up to 350 study centers in more than 30 countries worldwide. It is evaluating a monthly target dose of 1,020 mg with an optimised titration, aimed at maximizing exposure and minimising dose interruption throughout the study period for better detection of a potential clinical benefit. Both trials are expected to be completed in the second half of 2022.

About Roche in Alzheimer’s disease
For decades, advocacy groups, academia, industry and the broader healthcare community have collectively progressed our understanding of Alzheimer’s disease (AD) – with the hope that every step would help lead to advancements in treating this devastating disease. Given the complexity of Alzheimer’s on a disease and societal level, we anticipate the need for several treatment options to meet the multiple and diverse needs of all people living with Alzheimer’s and their caregivers. As both a pharmaceutical and diagnostics company, we’re in the unique position to contribute to this progress through our ongoing research and studies of investigational medicines for different targets, types and stages of Alzheimer’s and delivering tests to detect, diagnose and monitor the disease. We are hopeful that our ongoing research will lead to scientific progress that could impact millions of people. We are also working in over 70 partnerships with organizations from across the healthcare sector to accelerate progress and improve care for people with AD.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

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