OTSUKA PHARMACEUTICAL CO., LTD.

Otsuka Submits BLA for Sibeprenlimab: A Novel Targeted Therapy for IgA Nephropathy

2 months ago

• Otsuka has filed a Biologics License Application with the FDA for sibeprenlimab, a monoclonal antibody that selectively inhibits APRIL, a key cytokine in IgA nephropathy pathogenesis. • The submission is supported by successful Phase 2 ENVISION and Phase 3 VISIONARY clinical trials, which demonstrated significant reduction in proteinuria compared to placebo after nine months of treatment. • If approved, sibeprenlimab would offer patients a convenient subcutaneous injection administered every four weeks, with the option for self-administration at home, addressing a significant unmet need in IgA nephropathy treatment.

Aurinia Pharmaceuticals Reports Strong Q3 2024 Financial Results and Advances in Biotech Innovations

4 months ago

Aurinia Pharmaceuticals Inc. (AUPH) showcased impressive financial performance in Q3 2024, with revenues surpassing expectations and significant advancements in its biotech innovations, including the development of AUR200 and the approval of LUPKYNIS in Japan.

Schrödinger Announces Strategic Priorities for 2025, Advances Clinical Programs

4 months ago

• Schrödinger expands collaboration with Otsuka Pharmaceutical and anticipates $150 million upfront payment from Novartis in Q1 2025. • The company plans to present initial Phase 1 data for SGR-1505, SGR-2921, and SGR-3515 in 2025, targeting various cancers. • Schrödinger's co-founded companies, including Ajax, Nimbus, and Structure Therapeutics, reported significant clinical and financial progress in 2024.

Donidalorsen Shows Sustained Efficacy in Hereditary Angioedema Prophylaxis

5 months ago

• Donidalorsen demonstrates a sustained reduction in HAE attack rates and improved quality of life in patients, according to Phase 3 and Phase 2 clinical program analyses. • The investigational RNA-targeted medicine is under FDA review, with a PDUFA date set for August 21, 2025, positioning it for potential commercial launch. • Data from the OASISplus study show that donidalorsen effectively reduces HAE attack rates and improves quality of life in patients switching from other prophylactic treatments. • Long-term analysis of the Phase 2 open-label extension study reveals that donidalorsen maintains a 96% reduction in HAE attack rates from baseline up to three years.

FDA to Review Rexulti for PTSD Treatment Amidst PDUFA Delay

5 months ago

• The FDA will convene a Psychopharmacologic Drugs Advisory Committee (PDAC) to review Rexulti (brexpiprazole) in combination with sertraline for treating PTSD in adults. • The FDA's decision to host a PDAC meeting indicates a delay in the Prescription Drug User Fee Act (PDUFA) target action date, originally set for February 8, 2025. • Clinical trial data supports the combination of brexpiprazole and sertraline, showing statistically significant improvements in PTSD symptoms compared to sertraline alone. • Rexulti, developed by Otsuka and Lundbeck, is already approved for major depressive disorder, schizophrenia, and agitation associated with Alzheimer's disease.

Otsuka Seeks Approval in Japan for Bempedoic Acid to Treat Hypercholesterolemia

6 months ago

• Otsuka Pharmaceutical has submitted a New Drug Application (NDA) in Japan for bempedoic acid to treat hypercholesterolemia and familial hypercholesterolemia. • Phase 3 trial data showed bempedoic acid significantly lowered LDL-C by 25.25% compared to placebo in patients with statin intolerance or inadequate response. • Esperion Therapeutics retains commercialization rights in the U.S. and is pursuing further global expansion for bempedoic acid in other markets. • Bempedoic acid has demonstrated cardiovascular benefits, including reducing major adverse limb events in patients with peripheral artery disease.

Esperion Therapeutics Reports Increased Revenue and Reduced Net Loss in Q3 2024

6 months ago

• Esperion Therapeutics reports a net product revenue increase of $10.8 million compared to Q3 2023, driven by prescription growth of NEXLETOL and NEXLIZET. • The company's R&D expenses decreased by $4.5 million due to the completion of the CLEAR Outcomes study, contributing to a reduced net loss of $29.5 million. • Esperion anticipates that current cash resources, expected future net product sales, and revenue under collaboration agreements will be sufficient to fund operations for the foreseeable future.

Epilepsy Pipeline Shows Promise with Novel Therapies in Clinical Trials

7 months ago

• Over 90 epilepsy treatment therapies are under development by more than 75 companies globally, targeting various mechanisms of action and routes of administration. • Longboard Pharmaceuticals reported positive Phase Ib/IIa results for LP352 (bexicaserin) in developmental and epileptic encephalopathies (DEEs), showing a significant reduction in seizure frequency. • Amzell has initiated a study comparing AMZ002 with Vigabatrin for treating infantile spasms, a rare and severe form of epilepsy, to assess efficacy and safety. • Emerging therapies like RLS103, CT-010, Darigabat, and XEN496 are in different clinical trial phases, indicating potential advancements in epilepsy management.

Otsuka's Sibeprenlimab Shows Positive Phase 3 Interim Results for IgA Nephropathy

7 months ago

• Otsuka Pharmaceutical's sibeprenlimab demonstrated a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatinine ratio (uPCR) compared to placebo. • The Phase 3 VISIONARY trial met its primary endpoint after nine months of treatment in adults with IgA nephropathy. • Otsuka plans to discuss the interim results with the FDA, potentially leading to an accelerated regulatory submission for sibeprenlimab. • Sibeprenlimab targets APRIL, a key factor in the immune pathogenic cascade of IgA nephropathy, offering a potential new therapeutic strategy.

Difamilast Shows Comparable Efficacy and Safety to Delgocitinib in Atopic Dermatitis: A Matching-Adjusted Indirect Comparison

8 months ago

• A matching-adjusted indirect comparison (MAIC) study suggests difamilast 1% cream has comparable efficacy and safety to delgocitinib in treating moderate-to-severe atopic dermatitis (AD). • The MAIC analysis adjusted for differences in baseline characteristics between clinical trials of difamilast and delgocitinib to allow for a more accurate comparison. • Results indicated no statistically significant differences in the proportion of patients achieving EASI-50 or EASI-75, or experiencing adverse events, between the two treatments. • The findings support difamilast as a viable alternative for managing AD, particularly in patients where JAK inhibitors may not be suitable.

Lupkynis (Voclosporin) Approved in Japan for Lupus Nephritis Treatment

8 months ago

• The Japanese Ministry of Health, Labour, and Welfare approved Lupkynis (voclosporin) in combination with mycophenolate mofetil for treating lupus nephritis. • This approval was based on the AURORA Clinical Program, which demonstrated Lupkynis' efficacy and safety in treating lupus nephritis patients. • Aurinia Pharmaceuticals is eligible to receive a $10 million payment from Otsuka Pharmaceutical, along with royalties on net sales, following the approval. • Lupkynis, a second-generation calcineurin inhibitor, is now approved in Japan, the U.S., the U.K., the European Union, and Switzerland for lupus nephritis.

Phase III LEAP-012 Study Shows Promising Results for Intermediate-Stage HCC Treatment

11 years ago

The LEAP-012 phase III trial demonstrates that combining lenvatinib, pembrolizumab, and TACE significantly improves progression-free survival in patients with intermediate-stage hepatocellular carcinoma, compared to placebo plus TACE.