FDA approves Leqembi, a Drug for Dementia

Dementia Drug Leqembi approves by FDA | CIO Women Magazine

Israeli medical professionals and the relatives of patients with early-stage Alzheimer’s disease and related disorders now have reason for hope thanks to a recently FDA-approved medicine to treat dementia. Leqembi, a medicine developed by Eisai and Biogen, was initially authorised for a small number of uses in January. On Thursday, the drug’s approved uses were widened to cover a wider range of mental disorder. It had been demonstrated in medical trials to reduce symptoms by about 30%.

Finally, a Cure found!

“Leqembi is the first amyloid beta-directed antibody for the treatment of dementia disease to transition from an accelerated approval to a conventional approval. According to the FDA, the medication reduces amyloid plaques, which are a pathophysiological component of the disease and the drug’s mechanism of action.

After getting the Health Ministry’s clearance, the medication is anticipated to become available in Israel over the next few weeks. However, it is yet unknown whether the medication will be among those covered by health maintenance organisations (HMO) when the panel for drug approval next meets.

Alzheimer’s disease is the most prevalent of several degenerative brain diseases that can result in dementia. Memory loss and a shift in autonomous thinking and direction are some of the earliest signs. It appears as a continuous and irreversible decline in mental abilities. Simple tasks and communication become more difficult over time, and behavioural changes are often seen. The disorders have the potential to result in brain haemorrhage and a full loss of cognitive abilities.

FDA grants first ever approval for Dementia drug meant to slow disease

What Experts say?

According to Professor Ramit Ravona-Springer, Director of Psychogeriatric and Memory Clinic at the Sheba Medical Centre, “one of the leading theories regarding the cause of dementia and Alzheimer’s is the sticky amyloid plaques deposits in the brain which lead to a degenerative process and eventually to symptoms.” She added that the trial indicated a slowdown of the disease’s course. This is the first study to demonstrate effectiveness in creating medication to combat amyloid, achieving all objectives and criteria.

Prof. David Tanne, president of the Israel Neurological Association, praised the study that discovered drugs that can slow the degenerative process in cognitive function in Alzheimer patients in the early stages of the disease. “This is exciting news and a breakthrough in the treatment of serious illnesses that had no cure, and we are on the cusp of a revolution in the field,” Prof. Tanne said. “This is a call to doctors and HMOs to invest more resources than are currently available in an early diagnosis of patients showing a diminished cognitive capacity, and if the drug receives approval from the Health Ministry, it will provide hope for patients and their families,” he said.



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