(Información remitida por la empresa firmante)
STOCKHOLM, Oct. 24, 2023 /PRNewswire/ — BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) and partner Eisai are proud to announce today that TIME has selected lecanemab (lecanemab-irmb, brand name LEQEMBI® in the US and Japan) as one of the Best Inventions of 2023 in the medical care category.
Lecanemab is based on BioArctic’s founder Professor Lars Lannfelt’s research. It is the first and only fully approved treatment in the US and Japan for patients with mild cognitive impairment or mild Alzheimer’s disease that targets the underlying disease and slows down cognitive decline.
Gunilla Osswald, CEO of BioArctic:
“It is a great honor and tremendous recognition that lecanemab is included in TIME’s list of the world’s best inventions this year. It feels fantastic that we are part of driving the paradigm shift currently happening globally in the treatment of Alzheimer’s disease.”
Alzheimer’s disease is a type of dementia that affects memory, thinking, behavior, and a person’s ability to manage daily life. It is a chronic neurodegenerative disease that is both progressive and incurable, affecting millions of people worldwide.
TIME’s annual list of the best inventions includes “200 extraordinary innovations changing lives.” To compile the list, TIME sought nominations from its editors and correspondents around the world and through an open online application process, with a particular focus on growing fields such as AI, green energy, and sustainability. TIME then evaluated each candidate based on several criteria, including originality, efficacy, ambition, and impact.
The information was released for public disclosure, through the agency of the contact persons below, on October 24, 2023, at 4.50 p.m. CET.
For further information, please contact:
Oskar Bosson, VP Communications and IR
-E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80
Jiang Millington, Director Corporate Communication and Social Media
-E-mail: jiang.millington@bioarctic.se
Phone: +46 79 33 99 166
INDICATION
LEQEMBI is indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
WARNING: AMYLOID RELATED IMAGING ABNORMALITIES (ARIA)
· Monoclonal antibodies directed against aggregated forms of amyloid beta, including LEQEMBI, can cause amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur. Serious intracerebral hemorrhages >1 cm, some of which have been fatal, have been observed in patients treated with this class of medications.
oApolipoprotein E e4 (ApoE e4) Homozygotes: Patients who are ApoE e4 homozygotes (approximately 15% of Alzheimer’s disease patients) treated with this class of medications, including LEQEMBI, have a higher incidence of ARIA, including symptomatic, serious, and severe radiographic ARIA, compared to heterozygotes and noncarriers. Testing for ApoE e4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA. Prior to testing, prescribers should discuss with patients the risk of ARIA across genotypes and the implications of genetic testing results. Prescribers should inform patients that if genotype testing is not performed, they can still be treated with LEQEMBI; however, it cannot be determined if they are ApoE e4 homozygotes and at higher risk for ARIA.
· Consider the benefit of LEQEMBI for the treatment of Alzheimer’s disease and potential risk of serious adverse events associated with ARIA when deciding to initiate treatment with LEQEMBI
CONTRAINDICATION
LEQEMBI is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients of LEQEMBI. Reactions have included angioedema and anaphylaxis.
WARNINGS AND PRECAUTIONS
Amyloid Related Imaging Abnormalities
· LEQEMBI can cause ARIA-E and ARIA-H. ARIA-E can be observed on MRI as brain edema or sulcal effusions, and ARIA-H as microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with Alzheimer’s disease. ARIA-H associated with monoclonal antibodies directed against aggregated forms of beta amyloid generally occurs in association with an occurrence of ARIA-E. ARIA-H and ARIA-E can occur together. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, rarely can occur. Reported symptoms associated with ARIA may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms associated with ARIA usually resolve over time.
ARIA Monitoring and Dose Management Guidelines
· Obtain recent baseline brain magnetic resonance imaging (MRI) prior to initiating treatment with LEQEMBI. Obtain an MRI prior to the 5th, 7th and 14th infusions.
· Recommendations for dosing in patients with ARIA-E and ARIA-H depend on clinical symptoms and radiographic severity. Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
· Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment with LEQEMBI. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.
· There is no experience in patients who continued dosing through symptomatic ARIA-E or through asymptomatic, but radiographically severe, ARIA-E. There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E. There are limited data in dosing patients who experienced recurrent ARIA-E.
Incidence of ARIA
· In Study 2, symptomatic ARIA occurred in 3% (29/898) of LEQEMBI-treated patients. Serious symptoms associated with ARIA were reported in 0.7% (6/898) of patients treated with LEQEMBI. Clinical symptoms associated with ARIA resolved in 79% (23/29) of patients during the period of observation.
· Including asymptomatic radiographic events, ARIA was observed in LEQEMBI: 21% (191/898); placebo: 9% (84/897). ARIA-E was observed in LEQEMBI: 13% (113/898); placebo: 2% (15/897). ARIA-H was observed in LEQEMBI: 17% (152/898); placebo: 9% (80/897). There was no increase in isolated ARIA-H for LEQEMBI vs placebo.
ApoE e4 Carrier Status and Risk of ARIA
· In Study 2, 16% (141/898) of patients in the LEQEMBI arm were ApoE e4 homozygotes, 53% (479/898) were heterozygotes, and 31% (278/898) were noncarriers.
· The incidence of ARIA was higher in ApoE e4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Among patients treated with LEQEMBI, symptomatic ARIA-E occurred in 9% of ApoE e4 homozygotes compared with 2% of heterozygotes and 1% noncarriers. Serious events of ARIA occurred in 3% of ApoE e4 homozygotes, and approximately 1% of heterozygotes and noncarriers.
· The recommendations on management of ARIA do not differ between ApoE e4 carriers and noncarriers.
Radiographic Findings
(CONTINUA)