Teva Pharmaceutical Industries Ltd said on Wednesday its experimental drug to prevent migraine cleared a late-stage study, paving the way for a U.S. regulatory submission later this year.
Patients treated with Teva's drug, fremanezumab, experienced a statistically significant reduction in the number of monthly headache days for both monthly and quarterly dosing regimens, the Israel-based company said.
About 40 million Americans suffer from migraine - intense headache characterized by throbbing pain and sensitivity to light and nausea. The condition, which can last for days, is incurable.
Teva joins companies such as Amgen Inc, Eli Lilly Co and Alder BioPharmaceuticals Inc that are developing similar drugs to target calcitonin gene-related peptide, or CGRP, a protein involved in pain-signaling during migraine.
The most important data point is that the quarterly dosing regimen worked for Teva, Evercore ISI's Umer Raffat said, noting that Lilly and Amgen's compounds are being developed for use only on a monthly basis.
In the 1,130-patient trial, fremanezumab was evaluated against a placebo in patients suffering from chronic migraine - those who experience 15 or more headache days per month.
Data from a separate study in patients with episodic migraine - those who experience up to 14 headache days per month - is expected in the coming weeks.
Currently, patients are treated with triptans, a class of drugs that hit the market in the 1990s. These medicines work by constricting blood vessels in the brain and cannot be used in up to 35 percent of patients due to high cardiovascular risk.
A host of other drugs - including anti-depressants, medicines for hypertension and even botox - are also used to treat migraine but with little success.
Overall, migraine cost the United States roughly $36 billion a year in terms of healthcare and lost productivity, according to the Migraine Research Foundation.
The lack of effective medicines and the sheer number of patients guarantee that each company's drug, if approved, will eventually generate at least $1 billion in sales, analysts have forecast.
Teva's U.S.-listed shares were up about 1 percent at $28.11 in early trading on Wednesday.
(Reporting by Natalie Grover in Bengaluru; Editing by Arun Koyyur)