Eisai’s Lecanemab Drug  For Alzheimer’s Gets Breakthrough Therapy Designation From US FDA

Japanese pharmaceutical company Eisai Co and partner Biogen Inc have acquired the breakthrough therapy designation from the US Food and Drug Administration (FDA) for its experimental therapy lecanemab for patients suffering from early Alzheimer’s.

This particular drug reportedly tends to work similarly to Biogen’s Aduhelm that had attained approval in June itself.

Lecanemab separates sticky protein deposits named amyloid beta from a patient’s brain in the initial stages of Alzheimer’s. This cuts down the possible impact of loss of memory and an individual’s overall inability to look after oneself.

Eisai had rounded up the enrollment process in March in an integral year-and-long assessment of lecanemab in symptomatic patients of early Alzheimer’s.

Moreover, the drug is also being put through a large trial that will be carried out on asymptomatic individuals who show evidence of amyloid in their brains, Indian Express reports.

The breakthrough therapy designation is a program of the FDA that aims to fast-track the development and assessment of medicines for conditions that are serious or threatening to life.

This designation paves the way for further intensive guidance on a development initiative that is efficient and also for eligibility for rolling review and a prospective priority review too.