Migraine drug meets main late-stage studies goal
Lilly migraine treatment meets main goal in late-stage studies
Eli Lilly and Co said on Friday patients with episodic and chronic migraine reported fewer debilitating headaches after using the drugmaker’s experimental drug compared to those on placebo.
About 40 million Americans suffer from migraines, and the disease costs the United States about $36 billion annually in healthcare and lost productivity, according to the Migraine Research Foundation.
However, few effective treatments to manage such episodes of throbbing pain are currently available.
Lilly’s galcanezumab is among three other drugs racing to capture the 13 million patient population afflicted with a severe form of the condition.
Like rival treatments from Amgen Inc, Teva Pharmaceutical Industries Ltd and Alder Biopharmaceuticals Inc, galcanezumab targets a protein associated with pain signaling called CGRP.
Berenberg analyst Laura Sutcliffe noted that although the full data set has not been revealed yet, Friday’s news is good, adding that Lilly is on track to be a leader in the headache space.
Lilly bought CoLucid Pharmaceuticals Inc earlier this year for about $960 million, adding heft to its migraine portfolio and positioning itself to capture a bigger slice of the largely under-treated market.
The earlier-than-anticipated trial results on Friday mean that Lilly has closed the gap slightly to race-leaders Amgen and Novartis, Sutcliffe said in a client note.
Berenberg expects Lilly’s drug to bring in global sales of $1.10 billion by 2022.
Amgen Inc and Novartis said in November its migraine drug met the main goal of a late-stage study.
Lilly said it would submit a marketing application to the U.S. Food and Drug Administration for the treatment — which was being tested in patients with episodic and chronic migraine in two doses — in the second half of 2017.
Patients with chronic migraine getting once monthly 120 mg doses experienced a reduction of 4.8 days from baseline in monthly migraine days, while those on 240 mg experienced reduction of 4.6 days, Lilly said.
Those in the placebo arm experienced a 2.7-days reduction. The patients in the late-stage study for chronic migraine had an average of 19.4 migraine headache days per month at baseline.
The company is also evaluating galcanezumab for the treatment of cluster headache, with late-stage study results expected in 2018.
Analysts expectations, on average, are for galcanezumab to generate sales of about $471.7 million by 2022, according to data from Clarivate Analytics.
(Reporting by Ankur Banerjee in Bengaluru; Editing by Shounak Dasgupta)