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The positive opinion from the CHMP, the committee responsible for thescientific assessment of new medicinal products, will be reviewed by theEuropean Commission, which then has authority to approve medicines for usethroughout the European Union.
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The CHMP's positive opinion is based on 48-week analyses of plasma HIVRNA levels and CD4+ cell counts from the ongoing, randomised, controlled,open-label phase III trial ARTEMIS in antiretroviral treatment-naiveHIV-1-infected adults. Patients received 800 mg darunavir once daily with 100mg ritonavir as part of combination therapy.
Darunavir, co-administered with low dose ritonavir, is currentlyindicated in combination with other antiretroviral medicinal products for thetreatment of HIV-1 infection in highly pre-treated adult patients who failedmore than one regimen containing a protease inhibitor (PI). Darunavir wasgiven conditional approval by the European Commission in February 2007. Thefull marketing authorisation from the European Commission for treatment-naiveadult patients is expected in the coming months.
Important Safety Information
In the registrational studies, darunavir was generally well toleratedversus the investigator selected PIs. The majority of the adverse reactionsreported in patients who initiated therapy with darunavir 600 mgco-administered with 100 mg ritonavir twice daily were mild to moderate inseverity. Thirty percent of the patients experienced at least one adversedrug reaction (at least grade 2 in severity and considered by theinvestigator at least possibly related to darunavir co-administered with 100mg ritonavir). The most frequently (greater than or equal to 2 percent) ofthose reported adverse reactions were diarrhoea (3.9 percent),hypertriglyceridaemia (3.8 percent), rash (2.8 percent), nausea (2.6percent), hypercholesterolaemia (2.5 percent) and headache (2.0 percent). 2.6percent of the patients discontinued treatment due to adverse reactions.
Before taking darunavir, patients should tell their doctor if they haveany medical conditions, including liver problems, including hepatitis B or C,diabetes, symptoms of infections, change in body fat, haemophilia,musculoskeletal problems, or allergy to sulfa medicines and should tell theirdoctor if they are pregnant or planning to become pregnant or planning tobecome pregnant, or are nursing.
Darunavir should not be used in patients allergic (hypersensitive) todarunavir or ritonavir or with severe liver problems.
There were some relevant drug-drug interactions with other medicationscommonly used in HIV patient populations, such as other antiretroviralmedications. Patients should talk to their healthcare provider about all themedicines they are taking or plan to take, including prescription andnon-prescription medicines, vitamins, and herbal supplements.
Darunavir does not cure HIV infection or AIDS, and does not preventpassing HIV to others.
Please see full Summary of Product Characteristics for more details.
About Tibotec Pharmaceuticals
Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceuticalresearch and development company, with offices in Yardley, PA, USA and itsmain research and development operations in Mechelen, Belgium. Tibotec isdedicated to the discovery and development of innovative HIV/AIDS drugs andanti-infectives for diseases of high unmet medical need.
About Tibotec, a division of Janssen-Cilag
Tibotec, a division of Janssen-Cilag, brings innovative products forHIV/AIDS to patients in Europe, the Middle East and Africa focusing onpatients' and healthcare providers' specific needs in this disease domain.The company will also commercialise medicines to combat other viral diseasesin the future.
About Janssen-Cilag
Janssen-Cilag is a leader in traditional and biological medicines fordisorders such as gastroenterology, women's health, mental health andneurology as well as for pain, oncology, haematology and nephrology.
Tibotec Pharmaceuticals amd Janssen-Cilag are subsidiaries of the Johnson& Johnson family of companies.
(This press release contains "forward-looking statements" as defined inthe Private Securities Litigation Reform Act of 1995. These statements arebased on current expectations of future events. If underlying assumptionsprove inaccurate or unknown risks or uncertainties materialize, actualresults could vary materially from the Company's expectations andprojections. Risks and uncertainties include general industry conditions andcompetition; economic conditions, such as interest rate and currency exchangerate fluctuations; technological advances and patents attained bycompetitors; challenges inherent in new product development, includingobtaining regulatory approvals; domestic and foreign health care reforms andgovernmental laws and regulations; and trends toward health care costcontainment. A further list and description of these risks, uncertainties andother factors can be found in Exhibit 99 of Johnson & Johnson's Annual Reporton Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form10-K, as well as subsequent filings, are available online athttp://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson.The Company does not undertake to update any forward-looking statements as aresult of new information or future events or developments.)
SOURCE Tibotec Pharmaceuticals
