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TMC114 (Prezista) Receives Positive Opinion from the European Committee for Human Medicinal Products for Treatment Of HIV
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Europe EMEA Recommends Approval for TMC114
Johnson & Johnson Gets EU Backing for Its First HIV Medicine
By Christopher Elser
Dec. 15 (Bloomberg) -- Johnson & Johnson won the backing of a European Union health panel for its first AIDS drug, a tablet that may inhibit virus strains that can overcome other treatments.
The positive opinion from the European Medicines Agency mean the pill, called Prezista, may be approved within 90 days and be available in the 25 countries of the EU. The drug should get conditional authorization because not all the formal studies have been completed, the London-based agency said today in an e-mailed statement. The medicine was approved in the U.S. in June.
EMEA Report
Initial marketing authorisation applications
EMEA: December 15, 2006
The CHMP (EMEA) recommended the granting of a conditional marketing authorisation for Prezista (Darunavir), from Jansen-Cilag International NV, intended for the treatment of Human Immunodeficiency Virus (HIV-1) infected adult patients with advanced disease and limited treatment options. Conditional marketing authorisations are granted for medicines that are likely to have a significant benefit for patients, before all of the formal studies into its efficacy and safety have been completed. EMEA review began on 1 February 2006 with an active review time of 204 days.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE
SUMMARY OF POSITIVE OPINION_for PREZISTA
International Nonproprietary Name (INN): darunavir
On 14 December 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, _recommending to grant a conditional marketing authorisation for the medicinal product PREZISTA 300 mg film-coated tablets intended for the treatment of Human Immunodeficiency Virus (HIV-1) infected adult patients with advanced disease and limited treatment options. The applicant for this medicinal product is Janssen-Cilag International NV.
The active substance of PREZISTA is darunavir, a HIV protease inhibitor (ATC code: J05AE10). It acts by inhibiting the HIV enzyme protease, thus preventing formation of mature virus. Darunavir must be given with a small dose of ritonavir (as a booster), which decreases the breakdown of darunavir in the liver, resulting in higher levels of the substance in the blood.
The benefits with PREZISTA, when used with low dose of ritonavir, as part of a combination antiretroviral therapy, are its ability to reduce the amount of HIV in plasma (viral load) and to increase the number of T cells (specifically CD4 cells) in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor. In two randomised, controlled dose range finding Phase II trials (POWER 1 and POWER 2), patients taking darunavir at the recommended dose of 600mg with 100mg ritonavir and with food twice a day had larger reductions in their viral loads than patients taking other protease inhibitors with low dose ritonavir. Both groups of patients took their protease inhibitors with nucleoside reverse transcriptase inhibitors (NRTIs) and with or without the fusion inhibitor enfuvirtide, chosen on the basis of HIV resistance testing.
The most common reported adverse reactions included diarrhoea, headache, fatigue, vomiting and hypertriglyceridaemia. A pharmacovigilance plan for PREZISTA, as for all medicinal products, will be implemented as part of the marketing authorisation.
The approved indication is: "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). This indication is based on week-24 analyses of virological and immunological response from 2 controlled dose range finding Phase II trials and additional data from uncontrolled studies (see section 5.1 of the Summary of Product Characteristics).
In deciding to initiate treatment with PREZISTA co-administered with 100 mg ritonavir careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA". It is proposed that therapy with PREZISTA is initiated by a physician experienced in the management of HIV infection.
Detailed recommendations for the use of this product will be described in the Summary of Product Characteristics (SPC) which will be published in the European Public Assessment Report (EPAR) and will be available in all official European Union languages after the conditional marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit to risk balance for PREZISTA and therefore recommends the granting of the conditional marketing authorisation. Conditional approvals are granted for medicines that are likely to have a significant benefit for patients, before all of the formal studies into its efficacy and safety have been completed.
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