By Lisa Beilfuss
U.S health regulators on Wednesday expanded the approved use for
Eylea, Regeneron Pharmaceuticals Inc.'s (RGEN) vision drug, to
treat the most common eye disease affecting patients with a type of
retina swelling known as diabetic macular edema.
Regeneron noted that the approval from U.S. Food and Drug
Administration makes Eylea the only such treatment option approved
for less than monthly dosing after an initial monthly dosing
period.
Diabetic retinopathy is the most common diabetic eye disease and
the leading cause of blindness in adults in the U.S., the FDA said.
According to the Centers for Disease Control and Prevention,
diabetes affects more than 29 million people in the U.S., and 33%
of adults with diabetes ages 40 years or older had some form of
diabetic retinopathy, the FDA said.
The blockbuster drug, injected into the eye, is designed to
block the growth of new blood vessels and decrease the ability of
fluid to pass through blood vessels in the eye.
Regeneron reported $2.8 billion in global Eylea sales in 2014,
up 48% from the previous year. Sales of the drug are expected to
grow 25% to 30% in 2015 compared with 2014, according to guidance
the company issued last month.
The company partners with Bayer HealthCare, a unit of German
pharmaceutical company Bayer AG (BAYRY, BAYN.XE), to market the
drug outside of the U.S.
This is the fourth indication for which Eylea has been approved
in the U.S., according to Janney Capital Markets. Among other uses,
the drug already had been approved in the U.S. to treat wet
age-related macular degeneration, a chronic eye disease that causes
vision loss.
Shares in Regeneron fell 4.2% Wednesday to $453.99, amid a
broader market sell-off, but have still risen 47% over the past
year.
Write to Lisa Beilfuss at lisa.beilfuss@wsj.com
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