Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sevirumab · 2 trials · 3 indications
| Name | Type | Description |
|---|---|---|
| Sevirumab | DRUG | - |
Inclusion Criteria Concurrent Medication: Allowed: * Zidovudine (AZT) \< 600 mg/day. * Experimental maintenance or prophylactic therapy with an approved therapeutic agent for a non-viral opportunistic infection. * Trimethoprim / sulfamethoxazole (TMP / SMX). * Pyrimethamine / sulfadoxine. * Aeros...
Sevirumab is an investigational monoclonal antibody developed by Novartis AG for cytomegalovirus infections, including cytomegalovirus retinitis. It is a Phase 1 candidate in the infectious disease therapeutic area. It has been studied in patients with acquired immunodeficiency syndrome and CMV viremia, viruria, or retinitis.
Sevirumab is being studied for the treatment of cytomegalovirus infections and cytomegalovirus retinitis, including in patients with acquired immunodeficiency syndrome who have CMV viremia, viruria, or retinitis. It is an investigational agent and has not been established as a marketed treatment.
Sevirumab is developed by Novartis AG, which trades under the ticker NVS. The drug also appears in trial records under the code SDZ MSL-109, a human anti-cytomegalovirus monoclonal antibody.
Sevirumab is in Phase 1 clinical development. Two completed Phase I/II trials have evaluated the antibody in patients with acquired immunodeficiency syndrome and cytomegalovirus viremia, viruria, or retinitis. It is investigational and has not been approved by the FDA.
Sevirumab has been studied in two completed trials: NCT00002268, which assessed safety and antiviral effects of escalating doses in patients with acquired immunodeficiency syndrome and CMV viremia or viruria, and NCT00002016, which assessed safety and tolerance of escalating doses in patients with acquired immunodeficiency syndrome and CMV retinitis. Both were conducted in the United States.
Yes, SDZ MSL-109 is an alternative designation for Sevirumab, a human anti-cytomegalovirus monoclonal antibody. Trial records for NCT00002268 and NCT00002016 list the drug under the SDZ MSL-109 code, so searches for either name refer to the same investigational antibody developed by Novartis AG.