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 The injection, cangrelor, which won European approval in March, is
designed to prevent blood clots during angioplasty, a procedure to
widen narrow or clogged coronary arteries, which often includes the
use of stents.
The FDA rejected the blood thinner in April last year, after its
reviewers took issue with the way a pivotal trial, called
Champion-Phoenix, was conducted, and asked the company to reanalyze
its dataset.
Based on the company's resubmission, the FDA staff concluded on
Monday that "the Phoenix-study as a stand-alone trial was sufficient
to warrant approval of cangrelor". (http://1.usa.gov/1aJerSr)
The study, which tested more than 11,000 patients, showed that
cangrelor lowered the combined risk of death, heart attack, repeat
procedures and stent thrombosis — the formation of a blood clot at
the site of a stent.
Patients on cangrelor were 22 percent less likely to experience
these complications 48 hours after the procedure, than those who
took Plavix, Bristol-Myers Squibb Co's rival product, known
generically as clopidogrel.
"The benefit of cangrelor compared to clopidogrel is small, but the
risk is smaller," reviewers noted.
Monday's review comes two days before a panel of independent experts
recommend to the FDA whether the drug should be approved. The agency
typically follows the panel's recommendations.
The Champion-Phoenix trial followed two failed studies. The company
tweaked the design of the third trial to differentiate between heart
attacks associated with its drug and those that may have resulted
from the angioplasty.
Cangrelor has an edge over Plavix and other oral blood clot
preventers because it takes effect rapidly and leaves the system
about an hour after being administered, analysts said.
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Existing drugs keep working for five days or more, significantly
increasing the risk of serious bleeding if a patient needs emergency
or urgent follow-up procedures.
Cangrelor would also benefit patients who are unable to swallow
pills.
RBC Capital's Adnan Butt said he expects peak annual sales of the
drug to hit about $100 million-$200 million globally.
Heart disease is the leading cause of death in the world, accounting
for one in seven deaths in the United States, according to the
American Heart Association.
The company's shares were up 2.4 percent at $28.99 in premarket
trading.
(Reporting by Samantha Kareen Nair and Natalie Grover in Bengaluru;
Editing by Ted Kerr and Simon Jennings)
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