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European Regulators Approve Alzheimer’s Treatment Leqembi
European regulatory bodies have granted approval to Leqembi, an Alzheimer’s treatment, after initially rejecting the medication last summer. The decision to reconsider and ultimately approve the drug marks a significant development in the ongoing fight against this debilitating disease.
Green Light for Leqembi in EU and Affiliated Nations
The infused therapy, developed by Japanese pharmaceutical company Eisai and Biogen, based in Cambridge, Massachusetts, is now authorized for patients in the early stages of Alzheimer’s disease. Drugmakers announced on Tuesday that the approval extends to all 27 European Union member states, as well as Norway, Iceland, and Liechtenstein.
Initial Rejection and Reconsideration
In July, the European Committee for Medicinal Products for Human Use (CHMP) initially advised against granting marketing authorization for Leqembi. This initial negative assessment stemmed from concerns regarding potential side effects, notably brain bleeding and swelling, which, although rare, can pose significant risks to patients.
Subsequently, Eisai appealed to the committee for a reevaluation of their initial decision. Following this appeal, the CHMP revised its stance and recommended approval for Leqembi in November, paving the way for the final regulatory green light.
Leqembi’s Mechanism and Clinical Trial Results
Leqembi functions by eliminating amyloid plaques, the sticky protein deposits in the brain associated with Alzheimer’s. Extensive clinical trials have demonstrated that treatment with Leqembi resulted in a slowing of cognitive and memory decline by several months compared to participants who received a placebo. This finding offers a degree of hope for individuals in the early phases of this neurodegenerative condition.
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Market Context and Competitive Landscape
Eisai, the originator of Leqembi, is collaborating with Biogen Inc. in its commercialization. Leqembi and another therapy, Kisunla from Eli Lilly and Co., represent a new class of Alzheimer’s treatments. They are the first to convincingly demonstrate a tangible delay in cognitive deterioration for patients. Both Leqembi and Kisunla have already secured approval from regulators in the United States.
Kisunla’s EU Regulatory Path
Despite the progress with Leqembi, the European committee announced last month that Kisunla should not be approved at this time due to similar concerns about side effects. Eli Lilly, headquartered in Indianapolis, has indicated its intention to continue discussions with regulators through a re-examination process, aiming to secure approval for Kisunla in the European market.
Biogen Stock Response
Following the announcement of European approval for Leqembi, Biogen experienced a rise in its stock value. Shares increased by approximately $2, reaching $119 in premarket trading on Wednesday, reflecting investor optimism about the drug’s market potential.