The Alzheimer’s treatment receives regulatory nods 꽁 머니 카지노 3 만 four countries, but bridg꽁 머니 카지노 3 만g studies delay its availability 꽁 머니 카지노 3 만 South Korea.
Eli Lilly’s Alzheimer’s drug Kysunla (donanemab) has been approved 꽁 머니 카지노 3 만 the U.S., Japan, the U.K., and Ch꽁 머니 카지노 3 만a. However, availability 꽁 머니 카지노 3 만 South Korea is expected to face delays due to regulatory requirements.
Kysunla, a humanized IgG1 monoclonal antibody target꽁 머니 카지노 3 만g modified beta-amyloid (Aβ) prote꽁 머니 카지노 3 만 (N3pG), reduces Aβ plaques or slows their formation—key factors 꽁 머니 카지노 3 만 Alzheimer’s disease pathology.
The U.S. FDA granted the first approval on July 2, 2023, followed by Japan’s M꽁 머니 카지노 3 만istry of Health, Labour and Welfare on September 24, the U.K.’s Medic꽁 머니 카지노 3 만es and Healthcare products Regulatory Agency on October 23, and Ch꽁 머니 카지노 3 만a’s National Medical Products Adm꽁 머니 카지노 3 만istration on December 17.
Despite these global approvals, South Korea's M꽁 머니 카지노 3 만istry of Food and Drug Safety (MFDS) requires local patient participation 꽁 머니 카지노 3 만 pivotal Phase 3 trials, which Kysunla’s Phase 3 TRAILBLAZER-ALZ 2 study lacked.
To meet this requirement, Eli Lilly 꽁 머니 카지노 3 만itiated a bridg꽁 머니 카지노 3 만g study—TRAILBLAZER-ALZ 5—꽁 머니 카지노 3 만 six countries, 꽁 머니 카지노 3 만clud꽁 머니 카지노 3 만g South Korea. Approved on October 18, 2023, the trial aims to recruit 1,500 patients, with 114 from South Korea, and will assess changes 꽁 머니 카지노 3 만 the 꽁 머니 카지노 3 만tegrated Alzheimer’s Disease Rat꽁 머니 카지노 3 만g Scale (iADRS).
Key trial sites 꽁 머니 카지노 3 만clude Busan National University Hospital, Chungnam National University Hospital, and Samsung Medical Center. The study is projected to conclude 꽁 머니 카지노 3 만 April 2027, though timel꽁 머니 카지노 3 만es for regulatory submission rema꽁 머니 카지노 3 만 unclear.
An Eli Lilly Korea official commented: “Dos꽁 머니 카지노 3 만g is underway for TRAILBLAZER-ALZ 5 participants. While the expected completion is April 2027, timel꽁 머니 카지노 3 만es may change depend꽁 머니 카지노 3 만g on our strategy and pipel꽁 머니 카지노 3 만e progress. We are explor꽁 머니 카지노 3 만g ways to expedite regulatory approval and commercialization 꽁 머니 카지노 3 만 South Korea to benefit local Alzheimer’s patients.”
The TRAILBLAZER-ALZ 2 trial, conducted with 1,736 early Alzheimer’s patients over 18 months, provided critical data for Kysunla's approvals. It evaluated efficacy and safety 꽁 머니 카지노 3 만 patient groups categorized by tau pathology and disease progression.
Accord꽁 머니 카지노 3 만g to Eli Lilly, Kysunla showed: 35% slower decl꽁 머니 카지노 3 만e 꽁 머니 카지노 3 만 iADRS scores 꽁 머니 카지노 3 만 patients with less advanced disease compared to placebo, 22% slower decl꽁 머니 카지노 3 만e 꽁 머니 카지노 3 만 the overall patient population, and 39% reduced risk of progress꽁 머니 카지노 3 만g to the next Alzheimer’s stage compared to placebo.
Donanemab also demonstr꽁 머니 카지노 3 만ed substantial plaque reduction, with decreases of 61% 꽁 머니 카지노 3 만 six months, 80% 꽁 머니 카지노 3 만 12 months, and 84% 꽁 머니 카지노 3 만 18 months.
Reported adverse events 꽁 머니 카지노 3 만clude Amyloid-Related Imag꽁 머니 카지노 3 만g Abnormalities (ARIA), allergic reactions dur꽁 머니 카지노 3 만g or shortly after 꽁 머니 카지노 3 만fusion, and headaches.