Astellas Seeks First Japanese Approval for Geographic Atrophy Treatment with Avacincaptad Pegol
• Astellas Pharma has submitted a New Drug Application to Japan's MHLW for avacincaptad pegol, potentially becoming the first approved treatment for geographic atrophy in Japan.
• The submission is supported by GATHER1 and GATHER2 clinical trials, which demonstrated the drug's ability to slow GA lesion growth with a favorable safety profile over two years.
• Geographic atrophy affects over 5 million people globally, with 66% at risk of becoming legally blind without treatment, highlighting the significant unmet medical need.
Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007
Lin BioScience's investigational drug LBS-007 has been granted Fast Track Designation by the U.S. FDA for treating acute myeloid leukemia, highlighting its potential to address unmet medical needs in acute leukemia treatment. The company is conducting a Phase 1/2 trial in patients with relapsed or resistant acute leukemias across the US, Australia, and Taiwan.
Japan Approves Lunsumio (mosunetuzumab) for Relapsed/Refractory Follicular Lymphoma
• Chugai Pharmaceutical's Lunsumio (mosunetuzumab) has received approval in Japan for treating relapsed or refractory follicular lymphoma (R/R FL).
• Lunsumio, a CD20/CD3 bispecific antibody, offers a novel monotherapy approach with potential for durable remission in patients who have failed two or more prior therapies.
• Approval was based on the FLMOON-1 study in Japanese patients and an overseas Phase I/II trial, demonstrating complete response rates of 68.4% and 57.8%, respectively.
• The treatment duration is tailored to patient response, aiming to reduce the overall burden of treatment and improve outcomes for R/R FL patients.
LBS-007 Receives FDA Fast Track Designation for Acute Myeloid Leukemia Treatment
• Lin BioScience's LBS-007 has been granted Fast Track Designation by the FDA for acute myeloid leukemia (AML) treatment, expediting its development.
• LBS-007, a novel cell cycle inhibitor, is currently in Phase 1/2 trials for relapsed or resistant acute leukemias in the US, Australia, and Taiwan.
• The Fast Track designation aims to address the unmet medical need in AML, offering potential for more frequent FDA interactions and accelerated approval pathways.
• LBS-007 has demonstrated a promising safety profile in Phase 1 dose escalation, with no significant adverse effects observed, according to Lin BioScience.
GSK's Penmenvy Approved by FDA for Meningococcal Disease Prevention in Adolescents and Young Adults
• The FDA has approved GSK's Penmenvy vaccine for individuals aged 10-25, targeting five major serogroups of Neisseria meningitidis.
• Penmenvy combines antigenic components from GSK's Bexsero and Menveo vaccines, offering broader protection against invasive meningococcal disease (IMD).
• Clinical trials demonstrated a safety profile consistent with GSK's existing meningococcal vaccines, showing effective immune responses.
• The CDC's Advisory Committee on Immunization Practices will vote on recommendations for Penmenvy's use in adolescents and young adults.
Rituxan Approved in Japan for Pediatric Chronic ITP
• Zenyaku Kogyo received approval from the MHLW for Rituxan to treat chronic idiopathic thrombocytopenic purpura (ITP) in children.
• This approval addresses a request from the Japanese Society of Paediatric Haematology/Oncology for pediatric ITP treatment options.
• Rituxan, an anti-CD20 monoclonal antibody, offers a therapeutic option for children with ITP resistant to primary treatments.
• The drug eliminates B cells, which are thought to be a pathogenic factor in ITP, providing a new approach to treatment.
Chugai Files Tecentriq for R/R Extranodal Natural Killer/T-Cell Lymphoma in Japan
• Chugai Pharmaceutical has filed for approval of Tecentriq (atezolizumab) in Japan for relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type (R/R ENKL).
• The application is based on positive results from a Japanese phase II clinical trial (ATTACK study) demonstrating a 53.8% overall response rate in R/R ENKL patients.
• If approved, Tecentriq would be the first immune checkpoint inhibitor available in Japan for R/R ENKL, addressing a significant unmet need due to the poor prognosis and lack of standard treatment.
• The safety profile observed in the ATTACK study was consistent with Tecentriq's established safety profile in other tumor types.
Eli Lilly's Kisunla (Donanemab) Receives Approval in Japan for Early Alzheimer's Disease
• Eli Lilly's Kisunla (donanemab-azbt) has been approved in Japan for treating early symptomatic Alzheimer's disease, including mild cognitive impairment.
• The approval is based on the Phase III TRAILBLAZER-ALZ 2 study, which demonstrated a significant reduction in clinical decline in early-stage patients.
• Kisunla aims to remove amyloid plaques, potentially allowing patients to discontinue treatment once plaque clearance is achieved, reducing infusion burden.
• Japan is the second major market to approve Kisunla, offering a new treatment option for the country's rapidly aging population with rising dementia cases.
Evrysdi Approved in Japan for Pre-Symptomatic SMA and Infants Under 2 Months
• Chugai's Evrysdi (risdiplam) gains approval in Japan for treating pre-symptomatic spinal muscular atrophy (SMA) and infants under two months of age.
• The approval is based on Phase II RAINBOWFISH study results, demonstrating Evrysdi's efficacy and safety in pre-symptomatic SMA infants.
• Evrysdi, an oral SMN2 splicing modifier, becomes the first oral treatment option available for SMA patients of all ages after birth in Japan.
• This approval enables earlier intervention, potentially maximizing treatment benefits for SMA patients diagnosed through genetic testing.
EMA's Advisory Group to Review Lecanemab for Alzheimer's Treatment
• The European Medicines Agency's (EMA) Scientific Advisory Group (SAG) will discuss the marketing authorization application for lecanemab.
• Lecanemab, developed by BioArctic and Eisai, is under review for treating Alzheimer's disease.
• The European Commission's decision on lecanemab is expected in the second quarter of 2024, pending CHMP opinion.
• Lecanemab has already been approved in the United States, Japan and China for mild cognitive impairment and mild dementia due to Alzheimer's disease.
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