InterMune, Brisbane, CA, March 28 (DDMAC).

DDMAC reviewed a journal advertisement with a brief summary for Infergen (interferon alfacon-l) and found it to be false and misleading because it overstated the product's efficacy but omitted and minimized risk information.

The Indications and Usage section of the FDA-approved PI for Infergen states that it is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum antibodies and/or the presence of HCV RNA. Other causes of hepatitis--such as, viral hepatitis B or autoimmune hepatitis--should be ruled out prior to initiation of therapy with Infergen, the PI cautions.

DDMAC said the journal is misleading and overstates the product's efficacy because it claims that "only Infergen offers a proven treatment option for the significant and growing number of nonresponders and relapsers," referring to patients with chronic HCV infection who do not respond to or who relapse following initial drug treatment. But the agency pointed out that InterMune's claim is based on a 1998 study that involved treatment with Infergen after the initial failure of specific, older regimens.

Since 1998, however, a number of new regimens that consist of a pegylated interferon alfa in combination with ribavirin have been approved and emerged as the new standard-of-care, DDMAC explained. "By failing to point this out, the journal ad misleadingly implies that Infergen has been proven safe and effective for the treatment of patients who have failed these newer regimens," the agency stressed, adding that "FDA is unaware of substantial evidence or substantial clinical experience that supports the safety and efficacy of Infergen in the treatment of HCV-infected patients who have failed newer initial treatments."

Additionally, according to the PI, Infergen is associated with several risks, including the cause or aggravation of fatal or life-threatening neuropsychiatric, autoimmune, ischemic and infectious disorders. Other AEs may include suicidal ideation; severe cytopenias; decrease or loss of vision; retinopathy, including macular edema retinal artery or vein thrombosis; retinal hemorrhages and cotton wool spots; and optic neuritis. Also, papilledema may be induced or aggravated by treatment with Interferon alfacon-1 or other alpha interferons.

But InterMune neglected to mention these AEs in its ad, and the company failed to present an important warning concerning the need for caution when administering the drug to patients with preexisting cardiac disease due to the risk of hypertension, supraventricular arrhythmias, chest pain and myocardial infarction.

The journal ad also omitted warnings related to bone marrow suppression; and the ad failed to present specific information related to the risk of severe psychiatric AEs, thereby minimizing the risk of depression, suicide attempt or suicidal ideation. AE, F-B; Doc. 13768W

InterMune:

* Neglected to mention its ad an important warning concerning the need for caution when administering the drug to patients with pre-existing cardiac disease.

* Omitted warnings related to bone marrow suppression.

* Failed to present information related to the risk of severe psychiatric AEs, thereby minimizing the risk of depression, suicide attempt or suicidal ideation.