Lecanemab

The immunoglobulin market, valued at US$ 13.36 billion in 2023, is projected to reach US$ 28.70 billion by 2034, driven by its use in treating immunodeficiency and other applications. Key growth factors include immunodeficiency disorders, infections, and thrombocytopenia. North America leads with a 46% share, while Asia-Pacific is expected to grow fastest due to increased health spending and prevalence of autoimmune diseases. Recent advancements include subcutaneous injection therapies and acquisitions by major pharmaceutical companies.

UK and US regulators face challenges in providing access to new Alzheimer's treatments like Leqembi and Kisunla, despite FDA approval. Medicare's Coverage with Evidence Development (CED) policy restricts access, prioritizing clinical studies over patient treatment, and disproportionately affects communities of color. Other payers, like TRICARE and Cigna, also deny coverage, labeling these treatments as 'experimental.' The high cost of Leqembi, $26,500 annually, further complicates access, with CMS overestimating future costs. Advocates argue for equitable coverage, noting the potential of these treatments to delay severe dementia by several months to years.

Eisai Co., Ltd. announces the start of operations at Eisai Saudi Arabia, a wholly-owned subsidiary in Riyadh, focusing on pharmaceutical sales. Established in April 2024, it aims to build an in-house sales system, taking over commercial rights from local partners. The company plans to expand its product portfolio, including Methycobal, Fycompa, Lenvima, and Halaven, and has submitted an application for Alzheimer’s treatment lecanemab. Saudi Arabia’s pharmaceutical market, the largest in the Middle East, grew at an average rate of 7% from 2019 to 2023.

Annovis Bio Inc. (NYSE: ANVS) announces promising early research results for its lead drug, buntanetap, in combination with other approved Alzheimer's disease (AD) drugs, aiming to improve cognition, unlike current treatments like Leqembi and Kisunla that only slow decline. This positions Annovis Bio as a notable player in transforming AD treatment.

Swissmedic to decide by end of 2024 on approving lecanemab, the first new Alzheimer’s drug in two decades. The decision faces challenges due to safety concerns and cost-effectiveness. Lecanemab, approved in the US, Japan, China, and South Korea, targets both symptoms and underlying causes of Alzheimer’s. The European Medicines Agency rejected it, citing risks, while the UK authorized it but denied reimbursement. Swissmedic's decision will impact Alzheimer’s patients and drugmakers' investment in new treatments.

Blood tests for Alzheimer's show promise but lack FDA approval, with some experts skeptical of their clinical use. Though cheaper and less invasive than PET scans or lumbar punctures, these tests are not yet standardized and cannot diagnose the disease alone. The best biomarker, pTau-217, is emerging, with Precivity's C2N test considered one of the best available. Despite their potential, blood tests are not yet ready to replace more invasive diagnostic methods, and their effectiveness in diverse populations remains unclear.

Eli Lilly's Alzheimer's drug Kisunla (donanemab) gains approval in Japan, following US FDA approval in July. Kisunla targets early symptomatic Alzheimer's, showing significant cognitive decline reduction in the TRAILBLAZER-ALZ 2 study. Japan's aging population makes it a key market, with dementia cases expected to reach 5 million by 2030, mostly Alzheimer's. Lilly emphasizes Kisunla's cost-effectiveness due to fixed treatment duration.

Biogen and UCB report promising Phase-III trial data for lupus treatment, dapirolizumab pegol, potentially reshaping the market. UC Davis Health explores CAR T-cell therapy as an alternative for lupus and lupus nephritis, aiming for targeted treatment.

Eli Lilly's Alzheimer's drug, donanemab, approved by Japan's health ministry, offering another treatment option after Eisai and Biogen's Leqembi. Kisunla, sold in the U.S., slows memory and thinking problems by 29% but has risks of brain swelling and bleeding. Unlike Leqembi, Kisunla has finite dosing, allowing patients to stop treatment when amyloid plaques are no longer visible.

EMA's CHMP recommended approval for 8 new medicines and extended indications for 12 others, including treatments for cancers, hemophilia, meningococcus, and biosimilars for age-related macular degeneration. Updates to COVID-19 vaccines Spikevax and Comirnaty targeting new variants were also recommended. CHMP extended indications for mpox vaccine Imvanex and others, while refusing authorization for Syfovre. Bruno Sepodes was elected as new CHMP chair, prioritizing medicine quality, safety, and efficacy.