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FDA approves Medicines
Co's blood-clotting agent
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[May 01, 2015]
By Natalie Grover and Samantha Kareen Nair
(Reuters) - The U.S. Food and Drug
Administration on Thursday approved The Medicines Co's dry powder
blood-clotting agent for use in hospital settings, a month after the
treatment received approval in Europe.
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 The treatment, Raplixa, is a combination of two human plasma-derived
blood-clotting proteins - fibrinogen and thrombin.
(http://1.usa.gov/1HVGQSd)
Raplixa is used to control bleeding during surgery when conventional
aids are found ineffective. The treatment is approved for use in
combination with an absorbable gelatin sponge.
Failure to close surgical wounds completely can result in serious or
possibly life-threatening complications, including blood loss,
tissue damage, infection and excessive scarring.
The approval comes at a time Medicines Co is facing a drop in sales
of its lead product, Angiomax anticoagulant injection, which
accounted for over 80 percent of its 2014 revenue.
Earlier this month, the company estimated lower-than-expected
revenue for the first quarter, with chief executive Clive Meanwell
attributing the shortfall to a drop in Angiomax sales due to
potential competition from generic versions
RBC Capital analyst Adnan Butt said any drug approval for the
company "would be considered positive at this time" given the
uncertainty regarding Angiomax.
He expects the treatment to generate peak sales of about $100
million in the United States.
Raplixa was added to the New Jersey-based company's armory, after it
acquired in 2013 private Dutch biotech firm ProFibrix B.V, its
original developer.
The Medicines Co expects Raplixa to be complementary to its other
hemostatic product Recothrom Thrombin, which notched U.S. sales of
$64.4 million last year.
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The U.S. regulator pushed up by three months its scheduled decision
date, after the company amended its marketing application in
relation to its manufacturing specifications.
(http://1.usa.gov/1GFWTlu)
The Medicines Co estimates there are 110 million surgical procedures
per year worldwide which result in bleeding that requires a
hemostatic product.
The company's shares ended lower before news of the approval,
dropping 1.7 percent to $25.61 in trading on the Nasdaq.
(This version of the story adds analyst comment and details)
(Reporting by Natalie Grover and Samantha Kareen Nair in Bengaluru;
editing by Kirti Pandey and G Crosse)
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