Amgen's Infergen Approved; 1st New Product In 6 Years

Amgen has been granted approval by the US Food and Drug Administrationfor Infergen (interferon alfacon-1) for the treatment of chronic hepatitis C virus infection. This is the first new drug to be cleared for the biotechnology firm for six years, but is unlikely to make a significant contribution to sales, according to analysts.

Amgen's stock did not move dramatically after the drug's approval was announced. The stock rose $1.75 to close at $49.44 on NASDAQ on the day of the announcement (October 7), and remained at around that level until the Marketletter went to press.

The results of a Phase III clinical trial have shown that Infergen is an effective firstline treatment for HCV and may also benefit patients who have relapsed on interferon alfa-2b. The 704-patient study looked at 24 weeks' treatment with Infergen followed by an additional 24-week observation period.