Inebilizumab

FDA Approves First Targeted Therapy for IgG4-Related Disease: Amgen's UPLIZNA

11 days ago

• The FDA has approved Amgen's UPLIZNA (inebilizumab-cdon) as the first and only targeted treatment specifically for IgG4-related disease, following positive results from the Phase III MITIGATE trial. • The MITIGATE trial demonstrated an 87% reduction in disease flare risk compared to placebo, with the study enrolling 135 adults across 80 sites in 22 countries. • Multiple companies including Sanofi and Zenas BioPharma are advancing a robust pipeline of approximately 10 therapies for IgG4-related disease, potentially transforming treatment options for this rare inflammatory condition.

Amgen's Stelara Biosimilar Generates $150 Million in First Quarter, Highlighting Biosimilar Strategy Success

21 days ago

• Amgen's biosimilar of Johnson & Johnson's Stelara achieved $150 million in first-quarter sales, contributing to the company's $735 million total biosimilar revenue, which grew 35% year-over-year. • The biotech company's strategic investment in biosimilars now accounts for approximately 9% of total revenue, offsetting pressure on branded products while outperforming some of its innovative medicines. • Amgen continues expanding its biosimilar portfolio with recent launches of Eylea copycat and upcoming Soliris biosimilar, while also developing competitors to blockbuster checkpoint inhibitors Opdivo and Keytruda.

Amgen Reports Strong Global Demand in Q1 2025, Bolstering Long-Term Growth Outlook

21 days ago

• Amgen announced positive first quarter 2025 financial results, citing strong global demand across its product portfolio and successful new product launches. • Chairman and CEO Bob Bradway expressed confidence in Amgen's long-term growth prospects, supported by recent successful Phase 3 clinical trial results for several products. • The biotechnology company, which employs over 28,000 people globally, continues to focus on its mission of harnessing biology and technology to combat serious diseases.

Pacira BioSciences Secures Future of Exparel with Strategic Patent Settlement Agreement

a month ago

• Pacira BioSciences has reached a settlement agreement with Fresenius, Jiangsu Hengrui Pharmaceuticals, and eVenus Pharmaceuticals regarding patents for its pain management drug Exparel, protecting market exclusivity until 2030. • Under the agreement, Fresenius will begin limited-volume sales of generic bupivacaine liposome injectable suspension in early 2030, with gradual market share increases reaching the high thirties percent by the final years of the agreement. • The settlement strategically preserves Pacira's market dominance for its lead drug Exparel for nearly a decade before allowing controlled generic entry, significantly extending protection beyond potential patent challenges.

UPLIZNA Becomes First FDA-Approved Treatment for IgG4-Related Disease, Reducing Flare Risk by 87%

2 months ago

• The FDA has approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with IgG4-related disease, a chronic immune-mediated inflammatory condition that can cause permanent organ damage. • In the pivotal MITIGATE trial, UPLIZNA demonstrated an 87% reduction in flare risk compared to placebo and allowed nearly 60% of patients to achieve corticosteroid-free, flare-free complete remission. • The approval marks Amgen's expanding leadership in CD19-directed B-cell depletion therapies across multiple autoimmune diseases, including NMOSD, IgG4-RD, and potentially generalized myasthenia gravis.

FDA's April Decisions to Shape Future of Key Therapies: Dupixent, Opdivo, and Nipocalimab in Focus

2 months ago

• Several major pharmaceutical companies await critical FDA decisions in April, with Sanofi's Dupixent, Amgen's Uplizna, and Bristol's Opdivo all seeking approval for new indications. • Johnson & Johnson aims to establish a new therapeutic franchise with nipocalimab, potentially marking a significant expansion in their immunology portfolio. • Stealth Biotherapeutics faces a crucial regulatory milestone that industry analysts describe as a "day of reckoning" for the company's development strategy and market position.

Uplizna Shows Remarkable Efficacy in Reducing Flares and Glucocorticoid Dependence in IgG4-Related Disease

2 months ago

• Phase III MITIGATE trial demonstrates Uplizna (inebilizumab) significantly reduces flare risk in IgG4-related disease, with only 10% of treated patients experiencing flares compared to 60% in the placebo group. • The CD19-targeting monoclonal antibody proved particularly effective for patients with pancreatic and biliary manifestations of IgG4-RD, showing even greater benefits than in the overall study population. • Uplizna treatment led to higher rates of glucocorticoid-free complete remission, potentially establishing a new second-line standard of care following initial glucocorticoid therapy.

Immunovant Shifts Focus to Next-Gen Therapy Despite Positive Phase III Results for Batoclimab in Myasthenia Gravis

2 months ago

• Immunovant's batoclimab demonstrated statistically significant improvement in myasthenia gravis symptoms in Phase III trial, with high-dose patients showing a 5.6-point improvement on the MG-ADL scale versus 3.6 points for placebo. • Despite positive clinical outcomes, Immunovant announced it will not pursue regulatory approval for batoclimab in myasthenia gravis or chronic inflammatory demyelinating polyneuropathy due to competitive market pressures. • The company is pivoting resources to its next-generation anti-FcRn antibody IMVT-1402, with pivotal trials expected to begin imminently for both myasthenia gravis and CIDP indications.

Amgen's Uplizna Shows Sustained Efficacy in Myasthenia Gravis Patients Through One Year

2 months ago

• Amgen's Uplizna demonstrated durable efficacy in patients with acetylcholine receptor antibody-positive generalized myasthenia gravis, with 72.3% of treated patients showing significant improvement in daily living activities versus 45.2% on placebo at 52 weeks. • The anti-CD19 antibody therapy maintained its efficacy with an infrequent dosing schedule of just two doses per year following an initial loading dose, potentially offering a competitive advantage over current treatments requiring more frequent administration. • Regulatory filing for Uplizna in generalized myasthenia gravis is anticipated in the first half of 2025, with the FDA having already granted the therapy Orphan Drug Designation for this indication.

FDA Accepts Aldeyra's Reproxalap NDA for Dry Eye Disease with AbbVie Collaboration

5 months ago

• The FDA has accepted Aldeyra Therapeutics' New Drug Application (NDA) for reproxalap, a topical ocular therapy for dry eye disease, with a PDUFA date of April 2, 2025. • Reproxalap, a first-in-class RASP modulator, has demonstrated significant clinical efficacy and safety in reducing the signs and symptoms of dry eye disease in multiple late-stage trials. • Aldeyra has expanded its collaboration with AbbVie to accelerate pre-commercial activities, with AbbVie covering 60% of the costs and a potential $100 million upfront payment upon exercising its option. • The partnership includes up to $300 million in milestone payments and a profit-sharing model for U.S. commercialization, positioning reproxalap as a potential game-changer in dry eye disease treatment.

Novartis and Apellis Advance C3G Therapies Towards FDA Submission

6 months ago

• Novartis' Fabhalta (iptacopan) demonstrated significant proteinuria reduction in the Phase III APPEAR-C3G trial, meeting its primary endpoint and supporting regulatory submissions. • Apellis' Empaveli (pegcetacoplan) showed a substantial reduction in proteinuria and C3c deposit clearance in the Phase III VALIANT trial, indicating early efficacy in C3G patients. • Nephrologists express a strong interest in new C3G therapies that can slow eGFR decline and reduce proteinuria, addressing the urgent need for innovative treatments. • Spherix data suggests treatment preferences may be influenced by administration route, with Fabhalta's oral administration potentially offering an advantage.

FDA Grants Accelerated Approval to Tarlatamab for Previously Treated Extensive-Stage Small Cell Lung Cancer

6 months ago

• Tarlatamab (Imdelltra) receives accelerated FDA approval for extensive-stage small cell lung cancer (SCLC) post-platinum-based chemotherapy. • The approval was based on the DeLLphi-301 study, which demonstrated a 40% objective response rate among evaluable patients. • The median duration of response in the study was 9.7 months, with a significant proportion of responses lasting over 6 months. • Common adverse events included cytokine-release syndrome, fatigue, and pyrexia, necessitating careful monitoring and management.

Drug Development Updates