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Norvir Advisory

Abbott Laboratories Submits New Drug Application
to U.S. FDA for Reformulated Norvir

ABBOTT PARK, Ill., March 31 -- Abbott Laboratories today announced it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for Norvir (ritonavir) soft-gel capsules. Norvir is an HIV protease inhibitor for the treatment of patients with HIV infection and AIDS. A regulatory filing is currently under review by the European Agency for the Evaluation of Medicinal Products (EMEA) following a submission to the agency in January 1999. Regulatory filings in other countries where Norvir is sold will occur throughout 1999.

The filing follows intense reformulation work at Abbott after an announcement in July 1998 that a new crystalline structure of ritonavir, which affected how the capsule dissolved, would interrupt the production of Norvir capsules.

In the interim, Abbott increased production of the liquid form of ritonavir to allow patients to continue therapy without interruption.

The application provided to regulatory authorities was based in part on a soft-gel capsule formulation of Norvir in development prior to the capsule supply shortage encountered last year. The product was reformulated to accommodate a new and stable crystalline structure of ritonavir.

Abbott cannot predict the timing for product approvals worldwide. In the interim, Norvir oral solution (liquid) will continue to be available to all Norvir consumers.

In the United States, Norvir is indicated in adults in combination with other antiretroviral agents or as monotherapy for the treatment of HIV infection for patients with advanced disease. This indication is based on the results from a study that showed a reduction in both mortality and AIDS defining events for patients who received Norvir. Median duration of follow-up in this study was six months. The clinical benefit of Norvir for longer periods of treatment is unknown for patients with less advanced disease.

This indication is based on changes in surrogate markers in studies evaluating patients who received Norvir alone or in combination with other antiretroviral agents. Norvir has also been approved by the FDA for use in children between the ages of 2 and 16 based on safety and pharmacokinetic data. In the European Union, Norvir is indicated in combination with anti-retroviral nucleoside analogue(s) for the treatment of HIV-1 infected patients with advanced or progressive immunodeficiency. Norvir has also been cleared by the EMEA for use in children over 2 years of age.

Norvir is not a cure for HIV infection. People treated with Norvir may continue to acquire illnesses associated with advanced HIV infection, including opportunistic infections. Norvir may not be right for everyone, including people with liver disease, hepatitis or hemophilia. Redistribution/accumulation of body fat have been observed in patients receiving protease inhibitors. Elevated blood sugar levels have been reported in patients taking protease inhibitors. Allergic reactions ranging from mild to severe have been reported. Common adverse reactions include fatigue, vomiting, diarrhea, loss of appetite, abdominal pain, taste disturbance, tingling sensation or numbness in the hands, feet, or around the lips, headache and dizziness. Norvir should not be used with certain medications including some non-sedating antihistamines, sedative hypnotics, antiarrhythmics or ergot alkaloid preparations. Patients should talk with their physician or pharmacist. For more information about the currently available Norvir liquid formulation, see the Norvir full prescribing information.

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Notice: This is an IAPAC initiative that is under the sole direction of the IAPAC Norvir Advisory Committee. Contents of the IAPAC Norvir Advisory section of the IAPAC Web site are subject to the approval of the chair of the advisory committee and will reflect the recommendations of the committee members. Abbott Laboratories has no input in the content of the IAPAC Norvir Advisory section of the IAPAC Web site.