Lundbeck Q3 2019 Financial Results
Eptinezumab - Exciting upcoming newsflow with interesting LCM
potential
Regulatory:
*
★
*
U.S. PDUFA action date: 21
February 2020
Expected submission in Canada
(Q1 2020), EU (by end 2020),
followed by submissions for
approval in other regions around
the world
Ongoing studies:
* RELIEF study started in November
2019 (n = ~450)
There are several life cycle management opportunities
Indication
RELIEF study - "Treat & Prevent" (NCT04152083)
Assessing the efficacy of eptinezumab for acute migraine, defined as an
active intercurrent migraine occurring in those patients who are
candidates for preventive therapy.
Subjects will be randomized to receive a single dose of eptinezumab or
placebo in a 1:1 ratio. The total study duration will be approximately 4 to
12 weeks, including up to an 8-week screening period, with clinic visits
occurring on Screening, Day 0 (dosing day), and Week 4.
Other potential indications
- Medication overuse headache
- Cluster headache
Post-concussion headache
- Other pain syndroms
21
Landbec⭑View entire presentation