Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Erenumab · 2 trials · 2 indications
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥4 continuous hours, and meeting at least one of the following criteria: 1. ≥2 of the following pain features: * Unilateral * Throbbing * Moderate to severe * Exacerbated with exercise/physical activity 2. ≥1 of the following associated symptoms: * Nausea and/or vomiting * Photophobia and phonophobia
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: 1. ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity 2. ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia
| Arm | Type | Description |
|---|---|---|
| Erenumab | EXPERIMENTAL | Administered by pre-filled syringe |
| Placebo | PLACEBO_COMPARATOR | Administered by pre-filled syringe |
| AMG334 70 mg | EXPERIMENTAL | AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days |
| AMG334 140 mg | EXPERIMENTAL | AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days |
| Name | Type | Description |
|---|---|---|
| Erenumab | BIOLOGICAL | Administered by pre-filled syringe |
| Placebo | OTHER | Administered by pre-filled syringe |
key inclusion Criteria: 1. History of at least 5 attacks of migraine 2. ≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period 3. \>=80% diary compliance during the baseline period Key exclusion Criteria: 1. Older than 50 years of age at migraine o...
Erenumab is a monoclonal antibody used for migraine, including episodic migraine. It is an investigational therapy in Phase 3 clinical development for the prevention of migraine episodes. Erenumab is being studied in adult patients with episodic migraine and chronic migraine.
Erenumab targets the calcitonin gene-related peptide receptor, which plays a role in migraine pathophysiology. By blocking this receptor, Erenumab aims to reduce the frequency of migraine episodes. This mechanism is being evaluated in clinical trials for episodic and chronic migraine.
Erenumab is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting Phase 3 clinical trials to evaluate the efficacy and safety of Erenumab in patients with migraine.
Erenumab is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, one in episodic migraine and one in chronic migraine, but Erenumab remains under investigation.
Erenumab has been studied in two completed Phase 3 trials. NCT03333109 enrolled 900 adults with episodic migraine across multiple countries. NCT03867201 enrolled 557 adults with chronic migraine. Both trials were randomized, double-blind, and placebo-controlled, evaluating efficacy and safety.
Erenumab is also known as AMG 334. The clinical trial NCT03333109, titled 'Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients,' refers to Erenumab by its alternative name. Both names refer to the same investigational monoclonal antibody for migraine.