Alzheimer's, european medicines agency and Leqembi

Changing course, European regulators now say Alzheimer’s treatment Leqembi should be approved
Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be approved.
European committee takes a second look at Alzheimer’s drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting the drug.
Eisai wins over European regulators on Alzheimer’s drug Leqembi
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.
EU regulator backs Eisai-Biogen Alzheimer's drug after initial rejection
The European Union's drugs regulator on Thursday recommended approval of Eisai and Biogen's Leqembi for some patients with early Alzheimer's disease, reversing its initial decision from four months ago.
EMA recommends Leqembi for treatment of early Alzheimer’s disease
After re-examining its initial opinion, EMA’s human medicines committee, or CHMP, has recommended granting a marketing authorisation to Leqembi for treating mild cognitive impairment or mild dementia due to Alzheimer’s disease in patients who have only one or no copy of ApoE4,
EU Backs Leqembi: A Breakthrough in Alzheimer's Treatment
The European Union's drugs regulator has recommended approval for Eisai and Biogen's Alzheimer's drug Leqembi. This marks a potential first treatment approval in the EU for early Alzheimer's, focusing on patients without the ApoE4 gene variant.
EU drugs regulator recommends Alzheimer's drug from Eisai-Biogen
The European Union's drugs regulator on Thursday said it recommends approval of Eisai and Biogen's Leqembi in patients with early Alzheimer's disease, months after the agency first rejected the treatment.
Biogen up 5% after EMA recommends Leqembi for early Alzheimer’s disease
EST Biogen (BIIB) up 5% after EMA recommends Leqembi for early Alzheimer’s disease Published first on TheFly – the ultimate
EU Gives Green Light: Leqembi on the Verge of Alzheimer's Approval
The EU's drugs regulator recommends approval of Eisai and Biogen's Alzheimer's drug, Leqembi, for patients with early stages of the disease. The approval is limited to those with certain genetic profiles.
EU regulator reverses decision to block Alzheimer's drug lecanemab
The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at slowing cognitive decline in patients. In July, the Amsterdam-based European Medicines Agency (EMA) denied recommending approval of the drug made by Eisai and Biogen because it considered the risks - especially bleeding and swelling in the brain - to be greater than the potential benefits in a broad population.
European Watchdog Partially Approves New Alzheimer's Drug
Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer's disease, reversing an earlier decision not to give it the green light.
Ticker: Biogen Alzheimer’s drug gets second look in EU; Ford takes $165M hit on slow recall
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
FiercePharma9h
EMA changes tune, endorses Eisai and Biogen's Leqembi in restricted Alzheimer's population
Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | ...
EMA rethinks stance, committee now recommends Leqembi for Alzheimer’s disease
Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.
ALZFORUM10h
Leqembi: Side Effects No Worse in Clinical Use Than They Were in Trial
In Japan, clinical use is climbing faster, with about 4,500 people now on the drug. ARIA rates in Japan are half those in the U.S., which was also the case in the Phase 3 Clarity trial. Meanwhile, use ...
BioSpace3d
Leqembi, Kisunla and Beyond: The Next Wave of Alzheimer’s at CTAD 2024
With Eisai and Biogen’s Leqembi and Eli Lilly’s Kisunla launching onto the market, the 2024 Clinical Trials of Alzheimer’s ...
Eisai: Still Relatively Modest Market-Implied Expectations For Leqembi
Analysis of Leqembi's commercial potential and market outlook, with a focus on growth projections and investment ...
The Pharma Letter3d
BRIEF—Eisai updates Leqembi outlook
Sweden-based BioArctic saw its fall 7.5% to 139.90 kronor on Friday, after its announced that its partner, Japan’s Eisa, has updated its revenue outlook for the Alzheimer’s treatment Leqembi ...
BioSpace1d
5 Reasons Biogen’s Shares Have Dropped 36% in 2024
A slow launch for Alzheimer's medicine Leqembi, a lackluster pipeline and a challenging drug launch environment are just a ...