The Center for Drug Evaluation (CDE) website indicates that US-based Eli Lilly’s (NYSE: LLY) injectable donanemab is set to obtain the breakthrough therapy designation (BTD) status for use in early symptomatic Alzheimer’s disease (AD), including mild cognitive impairment caused by Alzheimer’s disease and mild Alzheimer’s disease. This marks a significant step forward in the development and potential approval of this innovative therapy.
Mechanism and Clinical Profile
Donanemab is a monoclonal antibody (mAb) that binds to the β Amyloid protein subtype N3pG, promoting the clearance of amyloid protein deposition in the brain. A Phase II clinical study demonstrated that donanemab significantly improved cognitive ability and daily living ability in Alzheimer’s disease patients compared to placebo, reducing amyloid deposition to levels seen in healthy individuals.
Regulatory and Development Milestones
Previously awarded BTD in the US, donanemab has been filed for marketing in China on a rolling submission basis. A Phase III clinical study is expected to commence, assessing the drug’s ability to prevent Alzheimer’s disease. Clinical trial approval in China was awarded in June 2022, further supporting the drug’s development and potential market entry.
Future Outlook
The anticipated BTD status for donanemab in China underscores Eli Lilly’s commitment to advancing treatments for early symptomatic Alzheimer’s disease. With demonstrated efficacy in improving cognitive and daily living abilities, donanemab has the potential to address significant unmet needs in this area. Eli Lilly’s ongoing clinical trials and regulatory efforts highlight its dedication to bringing innovative therapies to patients worldwide.-Fineline Info & Tech
