Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication AIMOVIG is indicated for the preventive treatment of migraine in adults. AIMOVIG is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine in adults. ( 1 ) FDA label
Also known as AMG334, Aimovig
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 used for the preventive treatment of migraine, including episodic migraine and chronic migraine, in adults. It is a monoclonal antibody developed for the neurology therapeutic area and has been studied in Phase 3 clinical trials in adult patients with these headache disorders.
Erenumab targets CALCRL, acting as an antagonist at this receptor. By blocking this target, erenumab is designed to interfere with the signaling pathway involved in migraine. This mechanism underlies its development as a preventive therapy for episodic and chronic migraine in adults.
Erenumab is developed by Novartis AG, which trades under the ticker NVS. Novartis has sponsored the Phase 3 clinical development program for erenumab in adult migraine patients, including trials conducted across multiple countries in Asia, Latin America, and the Middle East.
Erenumab is in Phase 3 clinical development. Its Phase 3 trials in adult episodic migraine and chronic migraine have been completed. The program includes randomized, double-blind, placebo-controlled studies, and the drug remains an investigational therapy in clinical development for migraine prevention.
Erenumab has been studied in Phase 3 trials including NCT03333109, which evaluated AMG 334 in adult episodic migraine patients with 900 participants, and NCT03867201, which studied erenumab in adult chronic migraine patients with 557 participants. Both trials are completed and enrolled adults aged 18 years and older.
Yes, erenumab is also known as AMG 334. The Phase 3 episodic migraine trial NCT03333109 is titled as a study of AMG 334, which is the same monoclonal antibody as erenumab. Both names refer to the same investigational therapy developed by Novartis for migraine prevention.