Approval Probability
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ML Risk
AMG334 Pre-Filled Syringe · 1 trial · 1 indication
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms.
| Arm | Type | Description |
|---|---|---|
| Placebo DB | PLACEBO_COMPARATOR | Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch |
| AMG334 140 mg DB | EXPERIMENTAL | AMG334 70 mg subcutaneous injections (2) administered every 4 weeks during Double-Blind Epoch |
| AMG334 140 mg DB cont on AMG334 140 mg | EXPERIMENTAL | AMG334 70 mg subcutaneous injections (2) during DB continued on AMG334 140 mg in Open-Label Epoch |
| Placebo in DB to AMG334 140 mg | EXPERIMENTAL | Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch |
| Name | Type | Description |
|---|---|---|
| AMG334 (70 mg) Pre-Filled Syringe (PFS) | BIOLOGICAL | Two injections of AMG 334 70 mg (equaling 140 mg total dose) will be administered via subcutaneous injection |
| Placebo Pre-Filled Syringe (PFS) | BIOLOGICAL | Subcutaneous injection of matching placebo |
Inclusion Criteria: * Documented history of migraine in the 12 months prior to screen * 4-14 days per month of migraine symptoms * \>=80% diary compliance during the Baseline period * Failure of previous migraine prophylactic treatments Exclusion Criteria: * \>50 years old at migraine onset * Pre...
AMG334 Pre-Filled Syringe is an investigational monoclonal antibody being developed for the prevention of episodic migraine in adults. It is administered as a pre-filled syringe injection and is currently in Phase 3 clinical development. The drug is intended for patients who have failed other migraine therapies.
AMG334 Pre-Filled Syringe is a monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) receptor. By blocking this receptor, it is designed to prevent the cascade of events that leads to migraine attacks. This mechanism is being evaluated in clinical trials for episodic migraine prevention.
AMG334 Pre-Filled Syringe is developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting the clinical development program for this investigational therapy in the neurology therapeutic area.
AMG334 Pre-Filled Syringe is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions for episodic migraine prevention.
AMG334 Pre-Filled Syringe has one completed Phase 3 trial, registered as NCT03096834. This randomized, double-blind, placebo-controlled study evaluated the effectiveness of AMG 334 injection in preventing migraines in adults who had failed other therapies. The trial enrolled 246 participants across multiple countries in Europe and Australia.
AMG334 Pre-Filled Syringe is the pre-filled syringe formulation of erenumab, a monoclonal antibody targeting the CGRP receptor. The drug is being developed by Novartis for episodic migraine prevention. This formulation is designed for self-administration, and its efficacy and safety are being evaluated in clinical trials.