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news.Cangene has announced that its HepaGam B has received orphan-drug exclusive approval from the FDA for the prevention of hepatitis B recurrence following liver transplantation in hepatitis B surface antigen-positive liver transplant patients.
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This approval gives HepaGam B, (Hepatitis B Immune Globulin Intravenous (Human)) seven years of market exclusivity and could facilitate the recovery of certain regulatory filing fees.
A drug can be granted orphan-drug designation if the disease or condition the drug is intended to treat affects fewer than 200,000 people in the US or, if the drug is a vaccine, diagnostic drug or preventative drug; will be administered to fewer than 200,000 people per year in the US. Once a product receives orphan-drug exclusive approval for use in the disease or condition, FDA will not approve another sponsor’s product for that use for seven years.
John Langstaff, president and CEO of Cangene, said: “This exclusivity further solidifies HepaGam B’s position in the US market as the only hepatitis B immune globulin approved for the prevention of hepatitis B recurrence following liver transplantation.”