U.S. FDA approves
Biogen's hemophilia A drug Eloctate
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[June 07, 2014]
By Toni Clarke
WASHINGTON (Reuters) - The
U.S. Food and Drug Administration said on Friday it
approved Biogen Idec Inc's long-lasting hemophilia A
drug, Eloctate, adding another product to the company's
nascent portfolio of drugs for non-malignant blood
Hemophilia A is a rare, inherited blood-clotting disorder that can
lead to prolonged bleeding, bruising and joint and tissue damage. It
is caused by deficient levels in the body of factor VIII, a protein
needed to clot the blood.
The FDA's ruling followed its approval in March of Biogen's
hemophilia B treatment, Alprolix. Biogen developed both drugs with
Swedish Orphan Biovitrum AB, or Sobi, and expects the products to
form the basis of a new non-malignant blood disorder portfolio.
"We see Alprolix and Eloctate as the anchor tenants in a growing
franchise," said Douglas Williams, Biogen's head of research and
development. "We're in this space to stay."
Biogen's biggest products are currently the multiple sclerosis drugs
Avonex, Tecfidera and Tysabri.
Eloctate is expected to generate annual sales of $1.5 billion by
2019, according to the average estimate of six analysts polled by
Thomson Reuters. Sales of Alprolix are expected to generate annual
sales of $286 million over the same time period.
Current treatments for hemophilia B generate about $1 billion a
year, according to Biogen, while the market for hemophilia A
therapies is worth about $6 billion.
Hemophilia A is the more common form of the disease, affecting about
16,000 people in the United States, Biogen said. Hemophilia B
affected about 4,000 people.
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Hemophilia drugs must be infused two to three times a week to
prevent bleeding episodes. Eloctate cuts the number of doses needed
per week to between three and five days.
Biogen has not set a price for the drug, but Tony Kingsley, head of
commercial operations, said the cost for patients who switch from a
short-acting product to Biogen's longer-acting product should be
roughly the same, even though they will be dosing themselves less
Last month, Weston, Massachusetts-based Biogen and Stockholm-based
Sobi said they would donate hemophilia drugs for use in developing
nations in quantities large enough to treat tens of thousands of
patients over the next decade.
The drugs will primarily be used in those nations for emergency
treatments rather than preventative care.
(Reporting by Toni Clarke; Editing by Sandra Maler and Peter Cooney)
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