Riyadh – Asdaf News:
Lecanemab now has a chance of receiving full FDA clearance after an advisory council for the US Food and medicine Administration unanimously determined that the medicine has “clinical benefit” for treating Alzheimer’s. FDA is expected to make a decision by July 6.
Marketed under the trade name Leqembi, lecanemab is one of the first dementia medications that seems to delay the course of cognitive loss. Leqembi binds to amyloid beta, a characteristic of Alzheimer’s disease, but it is not a cure.
Even though there were significant safety reservations owing to the medication’s link with some serious side effects, such as brain swelling and haemorrhage, the FDA in January approved Leqembi for use in patients with moderate cognitive impairment or mild dementia.
The accelerated authorization programme enables early approval of drugs that “fill an unmet medical need” and treat severe illnesses while studies are ongoing to confirm, verify, and characterise the therapeutic value of the treatment. The FDA may give the medicine traditional full approval if the results of those further studies indicate a benefit. However, the medication may be removed off the market if the confirmatory trials do not reveal any advantages.
The federal Centres for Medicare and Medicaid Services have stated that lecanemab will give larger coverage if it wins standard FDA clearance, meaning Medicare patients may have more access to the drug. The coverage will have certain restrictions, though.
