* Biogen hemophilia A drug effective in trial
* Plans to file with U.S. regulators in 1st half of 2013
* Will file with European regulators after children’s trial
(Updates with details, background)
By Toni Clarke
BOSTON, Oct 31 (Reuters) – Biogen Idec Inc said on
Wednesday its experimental treatment for patients with
hemophilia A, a disorder that inhibits coagulation of the blood,
controlled bleeding in a late-stage clinical trial.
Biogen, which makes the multiple sclerosis drugs Avonex and
Tysabri, said it plans to submit an application to market the
drug with the U.S. Food and Drug Administration in the first
half of 2013. It will file with European regulators after it
completes a study of the drug in children.
Last month, Biogen and its partner Swedish Orphan Biovitrum
AB (Sobi), reported promising results of a trial of
their drug to treat hemophilia B, a less common form of the
disease.
Hemophilia is a new disease area for Biogen.
Hemophilia A is caused by a lack, or insufficient amount of,
the blood coagulation factor VIII. Patients with hemophilia B
lack or have reduced levels of coagulation factor IX.
Biogen’s drugs are designed to cut the number of infusions
needed to control bleeding. Existing Factor VIII products must
be taken as many as three to four times a week. Factor IX
products must be taken intravenously two or three times a week.
In Biogen’s latest study, known as A-LONG, 98 percent of
bleeding episodes were controlled with one or two injections of
its long-lasting Factor VIII drug.
Individual and weekly preventative regimens resulted in
median annualized bleeding rates in the low single digits, the
company said.
The market for hemophilia A treatments is worth about $5
billion, according to Biogen, while the market for hemophilia B
treatments is about $1 billion
(Reporting By Toni Clarke; Editing by Alden Bentley and Gerald
E. McCormick)
