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A Second Opinion: Preparing for Eptinezumab's data in Chronic Migraine after study changes and additional data from ErenumabTicker(s): ALDR, AMGN, TEVA, NVS
A headache specialist who is familiar with the CGRP developmental landscape and data, but not working with ALDR specifically. An independent and informed voice will be essential.
Please describe your clinical practice in terms of Chronic and Frequent Episodic Migraine patients.Added By: joe_mccann
Do you have any history or relationship with the development of CGRPs as a class? If so which?Added By: joe_mccann
How concerned are you about the change from 12 weeks to 24 weeks for the first look at PROMISE 1 data?Added By: joe_mccann
Based on clinicaltrial.gov records it looks like enrollment has increased from 600 to 900 patients. How concerning is this to you? https://twitter.com/WilliamGerber1/status/852209231679893504/photo/1Added By: joe_mccann
How does the profile thus far of Eptinezumab look compared to Erenumab's STRIVE results?Added By: joe_mccann
What percent of the migraine population will use and IV vs. subcutaneous administration? Would that differ between frequent episodic vs. chronic migraine? What about IV administration would make it preferred vs. subcutaneous administration?Added By: user9bc04687
How does the recently reported STRIVE and ARISE Ph3 data from Amgen shape your thoughts on which CGRP Ab therapy is best? How does eptinezumab stack up against the competition in both frequent episodic and chronic migraine?Added By: user9bc04687
Do oral CGRP inhibitors currently in development have a realistic chance to succeed in the market based on what you know about safety and efficacy?
Any update on positive or negative safety/efficacy differences between receptor (Amgen) vs ligand (Alder, Teva, Lilly) CGRP inhibitors?
Any update on potential market size for CGRP inhibitors given Amgen/Novartis ARISE study only 1.1 day/month reduction vs placebo (2.9 vs 1.8 placebo) in episodic migraine and the STRIVE trial which showed 1.4 to 1.9 day reduction of episodic migraine day reduction vs placebo (3.2 to 3.7 vs 1.8 day). Are these reductions vs placebo going to create large demand?
What do you feel is the most important trial endpoint for CGRP inhibitors? Average headache reduction days, percent 100% responders, 75% responders, 50% responders? Other?
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- Top line data from PROMISE 2, a Phase 3 study of Eptinezumab in 1,500 Chronic Migraine patients ALDR, TEVA, AMGN Occurred On: Feb 26, 2018
- PROMISE 2 Phase 3 trial in Chronic Migraine Top Line data expected first half of 2018 ALDR Occurred On: Jan 08, 2018
- Alder (ALDR) Plans to Announce Top-Line Data From 24 Week Phase 2b Study of ALD-403 in Chronic Migraine Patients By Mid-Year 2016 ALDR Occurred On: Sep 15, 2016
- Alder (ALDR) Expects Top-Line Data from Phase III PROMISE 1 Trial Evaluating ALD403 in Frequent Episodic Migraines in H1 2017 ALDR Occurred On: Jun 27, 2017