EU regulator backs Eisai-Biogen Alzheimer’s drug

EU regulator backs Eisai-Biogen Alzheimer’s drug

Sub: Sci

Sec: Health

Context:

• The European Union’s drugs regulator, the European Medicines Agency (EMA), recently recommended the approval of Leqembi (a drug developed by Eisai and Biogen) for patients with early-stage Alzheimer’s disease.
• This decision marks a reversal from its initial rejection four months ago and could potentially make Leqembi the EU’s first approved treatment for the condition if the recommendation is accepted by the European Commission.

Narrow Patient Group:

• The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended Leqembi for a more specific group of patients: those with one or no copies of the ApoE4 gene variant.
• These patients are less likely to experience severe side effects, such as brain swelling or bleeding, observed in persons with two copies of ApoE4 gene variant.

About Alzheimer’s disease:

• Alzheimer’s disease is a progressive neurologic disorder that causes the brain to shrink (atrophy) and brain cells to die.
• Alzheimer’s causes a gradual decline in memory, thinking, behaviour, and social skills, and it is the most common cause of dementia.
• Its symptoms included memory loss, language problems, and unpredictable behaviour.