Cangene Corp. has received conditional Health Canada approval of its HepaGam B product to fight hepatitis B after liver transplants.
Cangene said Monday the notice of compliance covers prevention of hepatitis B recurrence following liver transplantation in adults with low levels of virus replication, and requires the company to continue a confirmatory clinical study.
HepaGam B, an immune globulin injection, is the only intravenous product licensed in Canada for this treatment.
Hepatitis B, which damages the liver, can recur after a liver transplant as a result of infection of the liver graft by virus that remained in circulation in the body.
"There are currently no other products licensed in Canada to prevent hepatitis B recurrence following liver transplantation and we are pleased to be able to answer the unmet medical need faced by these patients," stated Cangene CEO John Langstaff.