Anti-HIV Medication Prezista Receives Conditional Marketing Authorisation in the European Union
Centralised Procedure Authorises use in all 27 EU Member States, Plus Others
CORK, Ireland--(BUSINESS WIRE)--Tibotec Pharmaceuticals, Ltd. announced today that the European Commission has granted a conditional marketing authorisation for PREZISTA™ (darunavir, also known by the investigational compound number TMC114), a protease inhibitor for the treatment of HIV-1 infected patients.
This decision by the European Commission through a centralised procedure, signifies that the treatment is authorised for use in the European Union (EU), valid in all 27 EU member states. A conditional marketing authorisation was granted to PREZISTA, taken in combination with ritonavir and other antiretroviral medicinal products, because of its benefits for HIV-1 infected patients, however, more evidence is yet to be provided. Additional safety and efficacy data will need to be submitted to the EMEA annually until full authorisation is granted.
The timing of the availability of the product will be decided in discussions with national authorities and will vary from country to country.
PREZISTA, co-administered with 100 mg ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor (PI).
The approval was based on 24-week safety and efficacy data from POWER 1 and POWER 2, two ongoing, randomised, controlled trials involving 255 treatment-experienced adults. The results were supported by a 24-week analysis of the open label trials (POWER 3 analysis) of 327 patients who were initiated at the recommended dose of 600 mg PREZISTA boosted with 100 mg ritonavir twice daily.
POWER 1 and 2 Efficacy Results
In a pooled analysis of the POWER 1 and 2 studies, following 24 weeks of treatment:
POWER 3 Efficacy Results
The European Commission decision also was based on supportive data from the POWER 3 analysis, a non-randomized, open-label analysis of treatment-experienced patients similar to those of POWER 1 and POWER 2 and who received darunavir/rtv (600mg/100mg twice daily). Data from this large cohort (n=327) showed that after 24 weeks:
Additionally, the product labelling includes supportive 48-week long-term efficacy data from the pooled analysis of POWER 1 and POWER 2 in treatment-experienced patients who received darunavir /rtv (600mg/100mg twice daily). The 48-week analysis indicates that:
“The approval of PREZISTA marks an important step in the management of highly treatment-experienced patients,” said Professor Margaret Johnson, Chair of the British HIV Association (BHIVA) Executive Committee and Clinical Director of HIV/AIDS Services, Royal Free Hampstead, NHS Trust. “Finding additional therapy options for highly treatment-experienced patients is one of the greatest challenges in HIV care today, as many of these people are currently on treatments which, are either failing or have already failed. The data presented so far is promising and PREZISTA will provide a vital new option for these patients.”
“The approval of PREZISTA reflects the ongoing commitment of Tibotec to delivering therapeutic approaches that help people with HIV who have unmet needs,” said Roger Pomerantz, M.D., President of Tibotec.
Important Safety Information
PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
In the registrational studies, PREZISTA was generally well tolerated versus the investigator selected PIs. The majority of the adverse reactions reported in this data during treatment with PREZISTA co-administered with 100 mg ritonavir twice daily were mild to moderate in severity. The most frequently reported moderate to severe adverse reactions were diarrhoea (2.6%), vomiting (2.2%) and hypertriglyceridaemia (2.0%). The most commonly reported adverse reactions of any grade were nausea (7.2%), diarrhoea (6.6%) and headache (3.3%). Skin rash can also appear but this is usually mild to moderate. One percent of patients discontinued treatment due to adverse events. People who are allergic to darunavir or any of its ingredients, or ritonavir should not take PREZISTA.
Before taking PREZISTA, patients should tell their doctor if they have any medical conditions, including diabetes, liver problems, haemophilia, or allergy to sulfa medicines and should tell their doctor if they are pregnant or planning to become pregnant, or are nursing. PREZISTA should not be used in patients with severe liver problems.
There were some relevant drug-drug interactions with other medications commonly used in HIV patient populations, such as other antiretroviral medications, proton pump inhibitors, and H2 receptor antagonists. Patients should talk to their healthcare provider about all the medicines they are taking or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Please see full Product Information for more details.
PREZISTA was developed by Tibotec Pharmaceuticals Ltd. Tibotec, a division of Janssen-Cilag, will commercialise the product in Europe, Russia, Switzerland and other countries. The marketing authorisation holder for PREZISTA in Europe is Janssen-Cilag International NV. In the U.S., it is marketed by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P. In Canada, it is marketed by Tibotec, a division of Janssen-Ortho Inc.
PREZISTA/rtv is currently in Phase III comparative clinical trials in treatment-naïve (ARTEMIS) and less treatment-experienced patients (TITAN) versus Kaletra (lopinavir/ritonavir). In Phase III studies known as DUET 1 and 2, darunavir is being studied with an investigational NNRTI, TMC125, in heavily treatment-experienced patients. Clinical studies on the use of the product in HIV-infected paediatric patients are also ongoing.
For further information, please visit www.tibotec.com.
About Tibotec Pharmaceuticals Ltd.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company’s main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Tibotec Pharmaceuticals is developing a Global Access Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries. The Global Access Program for PREZISTA includes access pricing, registration, medical education for appropriate use and voluntary licensing.
Tibotec, a division of Janssen-Cilag, will bring innovative products for HIV/AIDS to patients in Europe, the Middle East and Africa. This new division was created within the Janssen-Cilag companies in October 2005 to focus on patients’ and health care providers’ specific needs in this disease domain. The company will also commercialise medicine against other viral diseases in the future.
Janssen-Cilag is a leader in traditional and biological medicines for disorders such as in gastroenterology, women’s health, mental health and neurology as well as for pain, oncology, haematology and nephrology.
Tibotec Pharmaceuticals, Ltd.
Hans Vanavermaete: +32 (0) 15 461 017
Kellie McLaughlin: +1 908 541 4176
Posted: February 2007