Health Canada has approved the company’s treatment for the control and prevention of bleeding episodes and routine prophylaxis.
Alprolix has been approved for the treatment of adults and children aged 12 and older, with haemophilia B. This is the first regulatory approval worldwide for Alprolix, which is currently under review by regulatory authorities in several other countries, including the United States, Australia and Japan, states Sobi in a press release.
“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,” said Geoffrey McDonough, President and CEO of Sobi. “We are proud to be part of this therapeutic advancement and look forward to bringing this treatment to people with haemophila.”
The Canadian approval of Alprolix is based on results from the global, phase 3 B-LONG study. According to Sobi, it demonstrated that Alprolix safely and effectively prevented, or reduced, bleeding episodes with prophylactic injections given once weekly or once every 10-14 days in adults and adolescents with severe haemophilia B. In addition, more than 90 percent of all bleeding episodes were controlled by a single Alprolix injection.