Eisai and Merck (MSD outside of the US and Canada) have announced that in a Phase III trial, Lenvima (lenvatinib) plus Keytruda (pembrolizumab) with transarterial chemoembolisation (TACE) did not achieve statistical significance for overall survival (OS) compared to TACE alone. The LEAP-012 trial evaluated the combination in… Read More
The UK National Institute for Health and Care Excellence (NICE) has reached its final decision on two Alzheimer’s treatments, denying their use on the NHS due to the therapies not providing “good value for money.” Eli Lilly’s donanemab and Eisai’s lecanemab were under final draft guidance by… Read More
The European Commission (EC) has granted Leqembi (lecanemab) Marketing Authorisation (MA) in the European Union (EU). The approval makes the medicine the first therapy that targets an underlying cause of Alzheimer’s disease (AD) to be granted a MA in the EU. Lecanemab is indicated for… Read More
Researchers from the UK’s Drug Safety Research Unit are calling for the robust monitoring of the safety of lecanemab, a new drug to treat Alzheimer’s disease (AD). In a review article, published in the British Journal for Clinical Pharmacology, the… Read More
The benefits of Alzheimer’s drug lecanemab (Leqembi) are too small to justify the cost of providing the treatment to NHS patients, the UK regulator has ruled. This was the decision by the National Institute for Health and Care Excellence (NICE) in draft guidance on the drug. Read More
Lecanemab-irmb (Leqembi), an anti-amyloid beta (Aβ) protofibril antibody, continues to show benefit for early Alzheimer’s disease (AD) patients over three years, according to new trial results. Eisai and Biogen shared the latest findings at the Alzheimer’s Association International Conference (AAIC) 2024, held in Philadelphia. Read More
Eisai has submitted a marketing authorisation application (MAA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody to the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. The MAA is for the treatment of early Alzheimer’s disease (AD) (mild cognitive impairment due to AD… Read More
Leqembi’s prospects in the Alzheimer’s disease market remain uncertain despite its advantages over Aduhelm, says analytics company GlobalData. Eisai and Biogen’s anti-amyloid beta (Aβ) monoclonal antibody (mAb), Leqembi (lecanemab), recently gained approval from the Food and Drug Administration (FDA) under the accelerated approval pathway for the treatment… Read More
