Mercaptopurine

FDA Approves Lilly's Omvoh (mirikizumab) for Crohn's Disease

4 months ago

• The FDA has approved Eli Lilly's Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohn's disease in adults, expanding its use for inflammatory bowel disease. • The approval was based on the VIVID-1 trial, which showed significant clinical remission and endoscopic response rates compared to placebo after one year of treatment. • Omvoh is the first biologic in over 15 years with Phase 3 two-year efficacy data at launch, demonstrating long-term disease control and visible healing of the intestinal lining. • Lilly has submitted marketing applications globally, aiming to provide a new treatment option for Crohn's patients and is working with insurers to enable patient access.

Inotuzumab Ozogamicin Approved for Pediatric Relapsed/Refractory B-Cell ALL

7 months ago

• The FDA has approved inotuzumab ozogamicin for pediatric patients aged 1 year and older with relapsed or refractory (R/R) CD22-positive B-cell acute lymphoblastic leukemia (ALL). • Clinical trials demonstrated that inotuzumab ozogamicin achieved complete remission (CR) in a significant proportion of patients, with high rates of minimal residual disease (MRD) negativity. • Inotuzumab ozogamicin, a CD22-directed antibody-drug conjugate, offers a targeted treatment option for pediatric R/R B-cell ALL, addressing a critical unmet need. • Studies suggest that a dose of 1.8 mg/m2 per cycle is effective and tolerable in pediatric patients, with manageable adverse events like thrombocytopenia and neutropenia.

Half-Dose Glucarpidase Effective in Reducing Toxic Methotrexate Levels

4 years ago

• A study demonstrates that half-dose glucarpidase effectively lowers methotrexate (MTX) levels in patients with high-dose MTX-associated acute kidney injury. • MTX plasma concentrations decreased by ≥ 97.7% within one day after half-dose glucarpidase injection, facilitating management with intensified folinic acid rescue. • The findings suggest that reduced glucarpidase doses could decrease the financial burden of MTX toxicity treatment without compromising efficacy. • Researchers advocate for dose-finding studies to optimize glucarpidase dosing based on pharmacokinetic analysis and clinical outcomes.

FDA Approves Lilly's Omvoh (mirikizumab) for Crohn's Disease

Inotuzumab Ozogamicin Approved for Pediatric Relapsed/Refractory B-Cell ALL

Half-Dose Glucarpidase Effective in Reducing Toxic Methotrexate Levels

Drug Development Updates