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MYL-1401A · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| MYL-1401A (Adalimumab) | EXPERIMENTAL | MYL-1401A initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose |
| Humira® (Adalimumab) | ACTIVE_COMPARATOR | Humira® initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose |
| Name | Type | Description |
|---|---|---|
| MYL-1401A (Adalimumab) | BIOLOGICAL | MYL-1401A initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose |
| Humira® (Adalimumab) | BIOLOGICAL | Humira® initial dose of 80 mg administered sc, followed by 40 mg sc given every other week starting 1 week after the initial dose |
Inclusion Criteria: 1. Subject has signed the informed consent form 2. Subject is aged 18 to 75 years, inclusive, at time of Screening 3. Subject has had moderate-to-severe chronic plaque psoriasis for at least 6 months * Subject has involved BSA ≥10%, PASI ≥12, and sPGA ≥3 (moderate) at Screen...
MYL-1401A is an investigational monoclonal antibody being developed for the treatment of psoriasis, specifically including psoriatic arthritis. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
MYL-1401A is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. It is being studied for its efficacy and safety in patients with psoriasis and psoriatic arthritis.
MYL-1401A is being developed by Viatris Inc., a global healthcare company listed on the NASDAQ under the ticker symbol VTRS. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
MYL-1401A is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 3 trial has been completed, and the drug remains under investigation for psoriasis and psoriatic arthritis.
MYL-1401A has one completed Phase 3 clinical trial, identified as NCT02714322, titled 'MYL-1401A Efficacy and Safety Comparability Study to Humira®'. This randomized, double-blind, active-controlled study enrolled 294 participants across Bulgaria, Estonia, Hungary, Poland, Russia, and Ukraine.
MYL-1401A is not the same as Humira, but it is being studied as a potential biosimilar to Humira. The Phase 3 trial was designed to compare the efficacy and safety of MYL-1401A to Humira in patients with psoriasis and psoriatic arthritis.