Amgen says migraine prevention drug meets main goal of study

June 8 (Reuters) - An experimental drug for prevention of
chronic migraine headaches from Amgen Inc AMGN.O met the main
goal of a midstage study by reducing the number of monthly
attacks compared with a placebo, the company said on Wednesday.
The biotech drug, erenumab, which is being co-developed with
Swiss drugmaker Novartis NOVN.S , was tested at two doses in a
12-week, 667-patient Phase II study of subjects who were
experiencing about 18 migraine days a month.
Patients who received either the 70 milligram or 140 mg
doses injected once monthly experienced a 6.6-day reduction in
monthly migraine days, according to initial results. That
compared with a 4.2-day reduction for those who received a
placebo, a difference deemed to be statistically significant.
Amgen expects to release more detailed data, including
secondary goals such as reduction of at least 50 percent in
monthly migraine days and change in cumulative monthly headache
hours, at a later date.
The company is also expecting data later this year from a
late stage study of the medicine for patients who suffer from
episodic migraines. Chronic was defined as having at least 15
headache days per month over 3 months, while 4 to 14 headache
days per month was considered episodic.
Between three and seven million Americans suffer from
chronic migraines, which often involve nausea, vomiting and
intense sensitivity to light and sound, in addition to
incapacitating head pain.
"Migraine is the sixth leading cause of disability
worldwide," Sean Harper, Amgen's research chief, said in a
statement.
The safety of erenumab was similar to placebo, the company
said. The most common side effects involved injection site pain
and upper respiratory tract infections.
Under the collaboration agreement with Novartis, Amgen holds
the sales rights for the United States, Canada and Japan, while
Novartis would sell the drug in Europe and the rest of the world
if it wins regulatory approval.