An experimental drug to treat breathing complications
tied to a common lung disease may be linked to more instances of
cardiovascular deaths at higher doses, U.S. regulators said.
The twice-daily drug known chemically as aclidinium bromide
helped patients with chronic obstructive pulmonary disease, or
COPD, breathe easier, Food and Drug Administration staff said
today in a report. Advisers to the agency are set to meet Feb.
23 to weigh whether safety questions about the medicine have
been adequately assessed.
COPD, tied to smoking as a cause, is an umbrella term for
conditions that make it difficult to breath, according to the
National Institutes of Health. If approved, the drug may have
$150 million in sales for New York-based Forest in 2015,
according to the average of two analysts’ estimates compiled by
“It is striking that all the cardiovascular deaths are
reported for the higher aclidinium dose,” the FDA said in its
report on the drug. “It is difficult to dismiss the apparent
imbalance in cardiovascular death between the treatment groups,
while at the same time, impossible to conclude that the data
represent a true safety signal,” the agency said.