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 The biotech drug, erenumab, which is being co-developed with Swiss
drugmaker Novartis, 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.
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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.
(Reporting by Bill Berkrot; Editing by Andrew Hay)
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