Tag #Biogen

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lemonde.fr

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Sep 9, 13:20

France's HAS Rejects Accelerated Approval for Alzheimer's Drug Leqembi

France's Haute Autorité de santé (HAS) rejected accelerated approval for Biogen and Eisai's Alzheimer's drug Leqembi due to modest efficacy and concerning side effects, despite its EU approval and patient advocacy.

France's HAS Rejects Accelerated Approval for Alzheimer's Drug Leqembi

France's Haute Autorité de santé (HAS) rejected accelerated approval for Biogen and Eisai's Alzheimer's drug Leqembi due to modest efficacy and concerning side effects, despite its EU approval and patient advocacy.

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What is the immediate impact of the HAS's decision on Leqembi's availability in France?

The HAS's rejection of accelerated approval means Leqembi will not have immediate access and reimbursement in France. This decision delays broader patient access, pending a standard approval process involving further negotiations.

zeit.de

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Aug 30, 07:15

Lecanemab (Leqembi) Alzheimer Drug Launches in Germany

Germany and Austria are the first EU countries to launch Lecanemab, a new Alzheimer's drug, on September 1st, offering treatment to a limited subset of patients due to cost and eligibility restrictions.

Lecanemab (Leqembi) Alzheimer Drug Launches in Germany

Germany and Austria are the first EU countries to launch Lecanemab, a new Alzheimer's drug, on September 1st, offering treatment to a limited subset of patients due to cost and eligibility restrictions.

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What is the immediate impact of Lecanemab's launch in Germany?

Lecanemab, marketed as Leqembi, is available in Germany and Austria as of September 1st. However, its impact is limited to approximately 200,000 of Germany's one million Alzheimer's patients due to eligibility criteria (only those with zero or one copy of the ApoE4 gene) and high costs (around €34,000 per year per patient).

zeit.de

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Aug 31, 10:20

Germany and Austria First in EU to Offer Lecanemab for Early-Stage Alzheimer's

Starting September 1st, Germany and Austria will be the first EU countries to offer Lecanemab (Leqembi), a new Alzheimer's drug that slows disease progression in early stages, approved for patients with mild cognitive impairment and at most one copy of the ApoE4 gene.

Germany and Austria First in EU to Offer Lecanemab for Early-Stage Alzheimer's

Starting September 1st, Germany and Austria will be the first EU countries to offer Lecanemab (Leqembi), a new Alzheimer's drug that slows disease progression in early stages, approved for patients with mild cognitive impairment and at most one copy of the ApoE4 gene.

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What is the immediate impact of Lecanemab's availability in Germany and Austria?

Lecanemab, under the trade name Leqembi, will be available in Germany and Austria from September 1st, offering a new treatment option for approximately 250,000 Germans with early-stage Alzheimer's who meet specific criteria (mild cognitive impairment and at most one copy of the ApoE4 gene). The drug, costing roughly €24,000 per patient annually plus €10,000 for tests and procedures, will initially be covered by health insurance.

zeit.de

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Feb 28, 19:10

EMA Recommends Approval of Alzheimer's Drug Lecanemab

The European Medicines Agency (EMA) recommends approving Lecanemab, an Alzheimer's drug, for early-stage patients with mild cognitive impairment or mild dementia after a previous rejection due to safety concerns; the drug only slightly slows disease progression and is suitable for a small patient su...

EMA Recommends Approval of Alzheimer's Drug Lecanemab

The European Medicines Agency (EMA) recommends approving Lecanemab, an Alzheimer's drug, for early-stage patients with mild cognitive impairment or mild dementia after a previous rejection due to safety concerns; the drug only slightly slows disease progression and is suitable for a small patient su...

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What is the significance of the EMA's recommendation to approve Lecanemab for Alzheimer's disease?

The European Medicines Agency (EMA) recommends approving Lecanemab, an Alzheimer's drug targeting underlying disease processes, for early-stage Alzheimer's patients with mild cognitive impairment or mild dementia. This follows a previous rejection due to safety concerns, but a new review found the benefits outweigh risks in a specific patient subgroup with a lower likelihood of severe side effects like brain swelling and microbleeds. The drug only slightly delays disease progression and is suitable for a small percentage of patients.

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