Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Cangene's HepaGam B Approved for New Indication | Contract Pharma

What are you searching for?

Sign in
Breaking News, Trials & Filings

Cangene’s HepaGam B Approved for New Indication

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Cangene Corp. received approval from the FDA for HepaGam B for the prevention of hepatitis B recurrence following liver transplantation in hepatitis B surface antigen (HBsAg)-positive patients. HepaGam B is Cangene’s Hepatitis B Immune Globulin Intravenous, which is a purified antibody or hyperimmune that is specific for the hepatitis B virus. Clinical data showed HepaGam B was highly effective at preventing hepatitis B recurrence and the dosing regimen used demonstrated anti-HBsAg levels that exceeded target therapeutic levels.

HepaGam B is distributed in the U.S. by Apotex Corp., which recently expanded its distribution by placing the drug within Novation, LLC’s product line, making HepaGam B directly available to Novation’s healthcare organizations in the U.S.

“This is a very important approval and addresses a significant medical need,” said Dr. John Langstaff, Cangene’s president and chief executive officer. “And with the recent agreement for distribution of this product with Novation, the timing could not be better,” he said.

HepaGam B was approved by the FDA last year for treatment following acute exposure to blood containing HBsAg, and was approved earlier this year by Health Canada for prevention of Hepatitis B recurrence following liver transplantation in adult patients.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters