Eli Lilly and Company (NYSE: LLY), a leading pharmaceutical corporation in the US, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug donanemab-azbt, marketed under the name Kisunla. The drug is administered as a 350 mg/20 mL injection every four weeks for intravenous infusion and is now approved for use in treating adults with early symptomatic Alzheimer’s disease (AD), including those with mild cognitive impairment (MCI) and individuals in the mild dementia stage of Alzheimer’s with confirmed amyloid pathology.
Kisunla’s Global Regulatory Milestones
This NMPA approval marks Kisunla’s fourth global approval, following regulatory green lights in the US, Japan, and Great Britain, where the drug was approved in July, September, and October of this year, respectively. Kisunla stands out as the sole amyloid plaque-targeting therapy with evidence supporting the discontinuation of treatment once amyloid plaques are effectively removed. This feature not only offers a potential cost-saving advantage but also reduces the number of infusions required for patients undergoing treatment.
The Significance of Kisunla’s Targeted Therapy
Kisunla’s approval in China is a significant step forward in the global fight against Alzheimer’s disease. Its ability to target amyloid plaques, a hallmark of Alzheimer’s, and the flexibility to stop treatment once the plaques are cleared, positions Kisunla as an innovative therapy option for patients and healthcare providers alike.-Fineline Info & Tech
Leave a Reply