Alector and GSK have achieved a major milestone in the field of neurodegenerative diseases with their breakthrough-therapy designation from the U.S. Food and Drug Administration (FDA) for their latozinemab drug candidate. This designation specifically applies to the potential treatment of frontotemporal dementia in patients with a progranulin gene mutation.
Frontotemporal dementia, a devastating condition often leading to early onset dementia, affects a significant number of individuals worldwide. In the United States alone, it impacts approximately 50,000 to 60,000 people, while in the European Union, the number rises to 110,000 individuals. Among these patients, those with a progranulin gene mutation make up 5% to 10% of all cases.
The FDA’s breakthrough-therapy designation is an acknowledgment of the urgent need for effective treatments and aims to streamline the development and review process for drugs addressing serious conditions. This designation is given when initial clinical evidence suggests that a drug may offer substantial improvements over existing therapies.
Alector, a renowned clinical-stage biotechnology company based in South San Francisco, California, entered into a partnership with GSK, a prominent UK pharmaceutical company, in July 2021. Together, they are working on the development and commercialization of progranulin-elevating monoclonal antibodies, including the promising latozinemab.
This significant advancement brings hope to individuals suffering from frontotemporal dementia and their families. The collaboration between Alector and GSK represents a significant step forward in addressing the challenges posed by this rare neurodegenerative disease.
