FDA approves Biogen's hemophilia B drug Alprolix
Send a link to a friend
[March 29, 2014]
By Toni Clarke
(Reuters) — Biogen Idec Inc has won U.S. approval for its
long-acting hemophilia B treatment Alprolix, the U.S. Food and Drug
Administration said on Friday.
Hemophilia B is a rare, inherited disorder in which
a person's blood does not clot properly, which can lead to prolonged
bleeding and bruising. It affects about 4,000 people in the United
States and 25,000 worldwide.
Alprolix is a bioengineered version of the blood coagulation factor
IX, a protein needed for normal blood clotting. Biogen is developing
the drug in partnership with Swedish Orphan Biovitrum AB. It
received approval in Canada a week ago.
Hemophilia drugs in general must be infused two to three times a
week to prevent bleeding episodes. Biogen's drug needs to be
administered once a week or once every 10 to 14 days.
The company is also developing a long-lasting drug, Eloctate, for
Hemophilia A, a more common form of the disease, that affects about
20,000 people in the United States. Patients with hemophilia A lack
or have reduced levels of coagulation factor VIII.
Current treatments for hemophilia B generate about $1 billion a
year, according to Biogen. The market for hemophilia A therapies is
worth about $6 billion.
[to top of second column]
Eloctate would compete with Baxter International Inc's drug
Advate. Baxter is seeking to develop its own long-acting version but
Biogen is expected to be first to the market.
Alprolix is expected to generate sales of $286 million by 2019,
according to Thomson Reuters data. Eloctate is expected to generate
sales of $1.1 billion.
(Reporting by Toni Clarke in Washington;
editing by David Gregorio)
[© 2014 Thomson Reuters. All rights
Copyright 2014 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.