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Boehringer Ingelheim submits Marketing Authorisation Application to European Union and to the FDA for investigational Anti-HIV agent Tipranavir

Pressmeddelande   •   Okt 25, 2004 09:00 CEST

Boehringer Ingelheim today announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for tipranavir. Simultaneously the documentation was submitted to the FDA.

Tipranavir is a non-peptidic protease inhibitor (NPPI) for the treatment of HIV-1 infection in combination with other antiretroviral agents in patients who are protease inhibitor experienced. The application is supported by data from Phase II and Phase III studies of tipranavir boosted with low-dose ritonavir (tipranavir/r) in more than 2500 patients worldwide.

Two large-scale Phase III clinical trials, RESIST-1 and
RESIST-2* form the foundation of the MAA for tipranavir. These studies were randomized, controlled, open-label trials designed to examine the safety and efficacy of tipranavir/r versus a low-dose ritonavir-boosted comparator protease inhibitor in treatment-experienced patients. Interim data from RESIST-1 will be presented at the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, DC this week.1 Results from this study show that tipranavir is a viable treatment option for patients who have failed other protease inhibitors.

“Boehringer Ingelheim is committed to the development of new therapies that will benefit people living with HIV/AIDS,” said Dr. Andreas Barner, Vice-Chairman of the Board of Managing Directors and Head of Corporate Board Division Pharma Research, Development and Medicine at Boehringer Ingelheim. “The submission for tipranavir brings us one step closer to providing a potent treatment when the HI virus has developed resistance to most commercially available protease inhibitors.”

Tipranavir is a non-peptidic protease inhibitor currently in Phase III of clinical development. In June 2004, Boehringer Ingelheim announced the enrollment of the first patient in a broad-scale global tipranavir Compassionate Use Program, which provides access to HIV-positive patients in desperate clinical need of new treatment options.

Tipranavir is also being evaluated for use in pediatric and treatment-naïve patient populations. Pivotal clinical studies are currently underway.

Based on available clinical and in vitro data, tipranavir is active against most strains of HIV-1 that are resistant to commercially available protease inhibitors. Ongoing studies are designed to confirm these data.

In studies to date, tipranavir has been well tolerated by most patients and has a safety profile similar to other PIs. The most commonly reported adverse events across all clinical trials were gastrointestinal-related and included diarrhea, nausea, fatigue, headache and vomiting. Consistent with other PIs, the most common laboratory abnormalities were elevated liver enzymes and triglycerides.

Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. Viramune® (nevirapine) is a product of original research done at Boehringer Ingelheim. Viramune® was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs. Boehringer Ingelheim is committed to the rapid development of the investigational non-peptidic protease inhibitor (NPPI) tipranavir in phase III clinical trials and recently acquired the nucleoside analogue (NRTI) MIV-310 currently in phase II development. The company is involved in basic research and is committed to improving HIV therapy by providing physicians and patients with innovative antiretrovirals.

* Note to the Editor:
RESIST stands for Randomized Evaluation of Strategic Intervention in Multi-Drug ResiStant Patients with Tipranavir.

Related links:
Boehringer Ingelheim`s global website on HIV/Aids

Boehringer Ingelheim GmbH
Corporate Division Communications
Judith von Gordon
55216 Ingelheim am Rhein
Phone: +49/6132/77 35 82
Fax: +49/6132/77 66 01

1 Hicks et al. RESIST-1: A Phase 3 Randomized, Controlled, Open-Label Multicenter Trial Comparing Tipranavir/Ritonavir (TPV/r) to an Optimized Comparator Protease Inhibitor/r (CPI/r) Regimen in Antiretroviral (ARV) Experienced Patients: 24-Week Data, 44th Interscience Conference on Antimicrobial Agents and Chemotherapy; October 31 - November 2, 2004, Washington, D.C. Abstract #3726.