Bristol-Myers Squibb hepatitis-B drug wins approval
The drug is an oral antiviral agent designed to block replication of the virus by interfering with its ability to infect cells.
An FDA panel recommended approval of the Baraclude earlier this month after suggesting clinical trial data showed the drug to be superior to other hepatitis B medicines.
However, testing of the drug in mice and rats caused cancerous tumors and "suggest a possible carcinogenic risk in humans," a BMS researcher Lois Lehman-McKeeman said in a Reuters report.
BMS submitted its NDA to the FDA for Baraclude on Sept. 29 and was granted a six-month priority review.