CHMP Issues Positive Opinion For Once-Daily Prezista(R) (Darunavir) As Part Of Combination Therapy For Treatment-Naïve Adults With HIV-1

Main Category: HIV / AIDS
Article Date: 28 Nov 2008 - 2:00 PDT

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The Committee for Human Medicinal Products (CHMP) has issued a positive opinion recommending approval for once-daily dosing of 800 mg PREZISTA® (darunavir) with low-dose ritonavir as part of combination therapy in treatment-naïve adults (those who have never taken HIV medication before). Darunavir, a protease inhibitor, was developed by Tibotec Pharmaceuticals, and Tibotec, a division of Janssen-Cilag, is the organisation responsible for marketing the brand in Europe.

The positive opinion from the CHMP, the committee responsible for the scientific assessment of new medicinal products, will be reviewed by the European Commission, which then has authority to approve medicines for use throughout the European Union.

The CHMP's positive opinion is based on 48-week analyses of plasma HIV RNA levels and CD4+ cell counts from the ongoing, randomised, controlled, open-label phase III trial ARTEMIS in antiretroviral treatment-naïve HIV-1-infected adults. Patients received 800 mg darunavir once daily with 100 mg ritonavir as part of combination therapy.

Darunavir, co-administered with low dose ritonavir, is currently indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor (PI). Darunavir was given conditional approval by the European Commission in February 2007. The full marketing authorisation from the European Commission for treatment-naïve adult patients is expected in the coming months.

Important Safety Information

In the registrational studies, darunavir was generally well tolerated versus the investigator selected PIs. The majority of the adverse reactions reported in patients who initiated therapy with darunavir 600 mg co-administered with 100 mg ritonavir twice daily were mild to moderate in severity. Thirty percent of the patients experienced at least one adverse drug reaction (at least grade 2 in severity and considered by the investigator at least possibly related to darunavir co-administered with 100 mg ritonavir). The most frequently (≥ 2 percent) of those reported adverse reactions were diarrhoea (3.9 percent), hypertriglyceridaemia (3.8 percent), rash (2.8 percent), nausea (2.6 percent), hypercholesterolaemia (2.5 percent) and headache (2.0 percent). 2.6 percent of the patients discontinued treatment due to adverse reactions.

Before taking darunavir, patients should tell their doctor if they have any 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 their doctor if they are pregnant or planning to become pregnant or planning to become pregnant, or are nursing.
Darunavir should not be used in patients allergic (hypersensitive) to darunavir or ritonavir or 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. 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.

Darunavir does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

Please see full Summary of Product Characteristics for more details.

About Tibotec Pharmaceuticals

Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and development company, with offices in Yardley, PA, USA and its main research and development operations in Mechelen, Belgium. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.

About Tibotec, a division of Janssen-Cilag

Tibotec, a division of Janssen-Cilag, brings innovative products for HIV/AIDS to patients in Europe, the Middle East and Africa focusing on patients' and healthcare providers' specific needs in this disease domain. The company will also commercialise medicines to combat other viral diseases in the future.

About Janssen-Cilag

Janssen-Cilag is a leader in traditional and biological medicines for disorders such as gastroenterology, women's health, mental health and neurology as well as for pain, oncology, haematology and nephrology.

Tibotec Pharmaceuticals and Janssen-Cilag are subsidiaries of the Johnson & Johnson family of companies.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://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 a result of new information or future events or developments.)

Janssen-Cilag

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