Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
gefurulimab · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Gefurulimab | EXPERIMENTAL | On Day 1, participants will receive a weight based loading dose followed by a weekly maintenance dose for up to 122 weeks. |
| Name | Type | Description |
|---|---|---|
| Gefurulimab | COMBINATION_PRODUCT | Combination product consisting of syringe prefilled with gefurulimab will be administered weekly via subcutaneous (SC) injection. |
Inclusion Criteria: United States of America (USA) specific inclusion criterion: * Participant must be 12 to \< 18 years of age at the time of signing the informed consent/assent. * All participants must be vaccinated against meningococcal infection from serogroups A, B, C, W, and Y within 3 years...
Gefurulimab is an investigational monoclonal antibody being developed by AstraZeneca PLC for generalized myasthenia gravis, a chronic autoimmune neuromuscular condition. It is currently in Phase 3 clinical development and has not been approved by the FDA. The program includes a pediatric study in patients with AChR-positive generalized myasthenia gravis.
Gefurulimab is being studied for the treatment of generalized myasthenia gravis, including in pediatric patients who are positive for acetylcholine receptor antibodies. It is an investigational therapy and is not yet approved for any indication. The ongoing Phase 3 trial is evaluating its use in this patient population.
Gefurulimab is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating the drug in generalized myasthenia gravis.
Gefurulimab is in Phase 3 clinical development. The only listed trial is a Phase 3 study that is currently recruiting participants. The drug remains investigational and has not received FDA approval.
Gefurulimab is being evaluated in a single Phase 3 trial, NCT06607627, titled a PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis. The trial is recruiting up to 12 participants across the United States, Brazil, Japan, Poland, and Taiwan.