PREZISTA(R)(darunavir) Oral Suspension Receives European Commission Approval for Young Children With HIV-1 Infection

BEERSE, Belgium, October 25, 2012 /PRNewswire/ --

Janssen-Cilag International announced today that the European Commission (EC) has approved a 100mg/ml oral suspension of PREZISTA® (darunavir), and the use of darunavir co-administered with low dose ritonavir, for the treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral therapy (ART)-experienced paediatric patients age 3 years and above, weighing at least 15 kg body weight. It must be taken in combination with other ARTs.

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The approval is based on a 48-week analysis of ARIEL, a Phase II, open-label trial to evaluate pharmacokinetics, safety, tolerability and antiviral activity of darunavir in combination with low dose ritonavir in treatment-experienced HIV-1 infected children from 3 to < 6 years of age.^[1]

"This approval is exciting news for young children with HIV, as there is a significant and often overlooked need in the availability of specifically formulated antiretroviral therapies for this patient population. An oral suspension that makes it easier for children with HIV to take their treatment as prescribed is very important for this group, who must maintain a lifetime of daily therapy to prevent the progression of HIV to AIDS," said Dr Avy Volari, MD, Chris Hani Baragwanath Hospital, Johannesburg, South Africa and lead author of the ARIEL Study.

Long-term durability of treatment is an important issue for young children living with HIV, which can be affected by challenges in adherence to therapy.  Strict adherence to treatment regimens and dosing schedules is crucial to prevent virological failure and the development of drug resistance.  Currently, one in eight children and adolescents with HIV in Europe experience virological failure of three drug classes within five years, which can severely limit treatment options into adolescence and adulthood.^[2]

The EC also recommended approval of the darunavir 100 mg/ml oral suspension for use in patients who are unable to swallow tablets, providing an additional way to receive treatment.

Darunavir oral bioavailability

The EC approval for the oral suspension was also based on TMC114-C169: a Phase I open label randomized crossover trial in healthy subjects to compare the oral bioavailability, to that of the 300mg tablet formulation in presence of low dose ritonavir under fasted and fed conditions.

About PREZISTA® (darunavir)

Darunavir is currently indicated for use in HIV-1 infected treatment-experienced children aged 6 to 18 years old and at least 20kg in body weight in combination with ritonavir and other ARTs. The licensed dosing is dependent on body weight and should not exceed 600 mg twice daily.

Since its initial approval in 2007, darunavir has also been indicated for use in HIV-1 infected treatment-naïve and treatment-experienced adult patients, including those who have been highly pre-treated, in combination with ritonavir and other ARTs. For treatment-experienced adult patients, the licensed dosing for darunavir (DVR) is 600 mg taken with 100 mg ritonavir twice daily with food or 800 mg taken with 100 mg ritonavir once daily with food for patients with no DRV Resistance Associated Mutations (RAMs)^[i] and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count ≥ 100 cells x 10⁶/L. For treatment-naive adult patients, the licensed dosing for darunavir is 800 mg taken with 100 mg ritonavir once daily with food.

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i. V11I, V32I, L33F, I47V, I50V, I54L/M, T74P, L76V, I84V, L89V

Important Safety Information

In the registrational studies, darunavir was generally well tolerated. The majority of the adverse reactions reported in patients who initiated therapy with darunavir co-administered with 100 mg ritonavir were mild to moderate in severity. The most frequent adverse reactions reported in clinical trials and as spontaneous reports are diarrhoea, immune reconstitution syndrome, nausea, pyrexia and rash. The most frequent serious reactions are diarrhoea, hepatitis, immune reconstitution syndrome, pyrexia and rash. Please see the Summary of Product Characteristics for a complete list of all possible side effects.

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 are nursing.

Darunavir should not be used in patients allergic (hypersensitive) to it or ritonavir or with severe liver problems.

Due to potential drug interactions, 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 Janssen in HIV - Commitment to Innovative Research & Development

Over the last five years, Janssen has launched three therapies for people living with HIV. Janssen has a long heritage in HIV and is committed to innovation in HIV therapies.  Janssen is constantly striving for improvements in efficacy, safety and dosing simplification and is committed to evaluating HIV treatments for a broad range of patients-from treatment-naïve to treatment-experienced-with the goal of helping all patients achieve an undetectable viral load and a better quality of life.

More information about Janssen can be found at http://www.janssen-emea.com 

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995.  The reader is cautioned not to rely on these forward-looking statements. 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 expectations and projections of Janssen Pharmaceutica NVand/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, 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; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies.  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 January 2, 2011.  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.  Neither Janssen Pharmaceutica NV nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.

References

1. Janssen. Data on File. Beerse. 2012
2. NAM AIDSmap. 'One in eight European children with HIV experienced failure of three drug classes within five years.' Available at URL: http://www.aidsmap.com/One-in-eight-European-children-with-HIV-experienced-failure-of-three-drug-classes-within-five-years/page/1777790/. Last accessed August 17, 2012.

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