Canada Approves New Hemophilia Drug; Expected To Hit U.S. Market Later This Year

A new drug has been approved in Canada for treating Hemophilia B. Alprolix,

The drug will help "control and prevent" bleeding episodes and prophylaxis, Virtual Strategy Magazine reported.

"This first approval of this long-acting therapy for people with haemophilia B is an important milestone in our joint collaboration with Biogen Idec and marks the first significant advance in the treatment for this group in almost 20 years," Geoffrey McDonough, President and CEO of Sobi said, Virtual Strategy Magazine reported. "We are proud to be part of this therapeutic advancement and look forward to bringing this treatment to people with haemophila."

Hemophilia B is an inherited disorder that inhibits the blood from clotting. It affects 4,000 people in the U.S. and about 25,000 worldwide, Reuters reported.

The drug's approval was based on a global, phase 3 B-LONG study. The researchers tested the drugs in 123 males over the age of 12 who suffered from the condition, Virtual Strategy Magazine reported.

The most common adverse effects related to the drug were found to be the common cold, "the flu, joint pain, upper respiratory tract infections, hypertension, and headache," Virtual Strategy Magazine reported.

The drug will be the "first long-acting fully recombinant clotting factor therapy."

It uses a naturally occurring pathway to make the drug last longer inside the body. The drug is in partnership with Swedish Orphan Biovitrum AB; it is expected to be approved in the U.S. later this year, Reuters reported. It was created in collaboration with Biogen Idec.

In addition to excessive bleeding, people suffering from hemophilia often have symptoms such as pain from prolonged bleeding episodes "irreversible joint damage and life-threatening [hemorrhages]," Virtual Strategy Magazine reported. Prophylactic injections of factor IX are often used to replace the missing clotting material that controls bleeding; this can help stop current bleeding episodes and help prevent excessive bleeding in the future.

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