Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MYL-1401H · 2 trials · 3 indications
Pharmacokinetics as measured by total AUC after extrapolation from time t to time infinity
Pharmacokinetics as measured by peak serum concentration of Pegfilgrastim
| Arm | Type | Description |
|---|---|---|
| MYL-1401H | EXPERIMENTAL | MYL-1401H |
| Neulasta | ACTIVE_COMPARATOR | Neulasta |
| Treatment A | EXPERIMENTAL | MYL-1401H: single subcutaneous injection (2mg) |
| Treatment B | ACTIVE_COMPARATOR | EU-Neulasta: single subcutaneous injection (2mg) |
| Treatment C | ACTIVE_COMPARATOR | US-Neulasta: single subcutaneous injection (2mg) |
| Name | Type | Description |
|---|---|---|
| MYL-1401H | BIOLOGICAL | During each chemotherapy cycle MYL-1401H (6 mg) is administered s.c. 24 hours after chemotherapy. |
| Neulasta | BIOLOGICAL | During each chemotherapy cycle Neulasta (6 mg) is administered s.c. 24 hours after chemotherapy. |
| EU-Neulasta | BIOLOGICAL | - |
| US-Neulasta | BIOLOGICAL | - |
Inclusion Criteria: * Signed and dated written informed consent. * Patients ≥18 years. * Women of child-bearing potential must agree to use effective methods of birth control during the treatment period from the first dose of study drug until 6 months following the last dose of study drug. * Newly ...
MYL-1401H is a monoclonal antibody being developed by Viatris Inc. (VTRS) for use in breast neoplasms and healthy volunteers. It is currently in Phase 3 clinical development for these indications, with studies also evaluating its use in chemotherapy-induced febrile neutropenia.
MYL-1401H is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. It is being studied in oncology, specifically for breast neoplasms, and in healthy volunteers for pharmacokinetic and pharmacodynamic evaluations.
MYL-1401H is being developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker symbol VTRS. The company is conducting clinical trials to evaluate the drug's efficacy and safety in breast cancer and related conditions.
MYL-1401H is in Phase 3 clinical development. It has completed one Phase 3 trial and one Phase 1 trial. The drug is investigational and has not been approved by regulatory authorities, as it is still undergoing clinical evaluation.
MYL-1401H has been studied in two completed trials. NCT02467868 was a Phase 3 study in breast neoplasms and chemotherapy-induced febrile neutropenia with 193 participants. NCT02479646 was a Phase 1 pharmacokinetic and pharmacodynamic study in healthy volunteers with 218 participants.
MYL-1401H is being studied in comparison to Neulasta (pegfilgrastim). Clinical trials have evaluated MYL-1401H against EU-sourced and US-licensed Neulasta, suggesting it may be a biosimilar candidate, but the available information does not confirm that MYL-1401H is the same as Neulasta.