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Date: 2015-10-22

Type of information: Positive opinion for the granting of a Market Authorisation in the EU

Product name: Edurant®

Compound: rilpivirine

Therapeutic area: Infectious diseases

Action mechanism:

non-nucleoside reverse transcriptase inhibitor. Rilpivirine is a second-generation non-nucleoside reverse transcriptase inhibitor. It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to make more viruses in the cells it has infected. By blocking this enzyme, rilpivirinz, taken in combination with other antiviral medicines, reduces the amount of HIV in
the blood and keeps it at a low level. 

Company: Janssen-Cilag International, a J&J company (USA - NJ) Tibotec Pharmaceuticals J&J (USA)

Disease:

HIV-1 infection in adults who have never taken HIV therapy (treatment-naïve)

HIV-1 infection in patients 12 years of age and older with a viral load ? 100,000 HIV-1 RNA copies/ml

Latest news:

* On 22 October 2015, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a change to the terms of the marketing authorisation for Edurant®. The CHMP adopted an extension to the existing indication as follows: “Edurant®, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients 12 years of age and older with a viral load ? 100,000 HIV-1 RNA copies/ml. As with other antiretroviral medicinal products, genotypic resistance testing should guide the use of Edurant®. 

* On November 28, 2011, Edurant® has been approved in the EU in combination with other antiviral medicines to treat adult patients infected with human immunodeficiency virus type 1 (HIV-1). It is only used in patients who have not received anti-HIV treatment before and who have viral load of no more than 100,000 HIV-1 RNA copies/ml. Edurant® was investigated in two main studies in 1,368 previously untreated patients infected with HIV-1. In the first study, Edurant® was compared with another NNRTI called efavirenz, when both medicines were given in combination with a fixed regimen of antiviral medicines consisting of tenofovir disoproxil and emtricitabine. In the second study, Edurant® was compared with efavirenz, when both medicines were given in combination with a fixed regimen of antiviral medicines consisting of tenofovir disoproxil and emtricitabine or two other nucleoside or nucleotide reverse transcriptase inhibitors. In both studies, the main measure of effectiveness was based on the reduction in viral load. Patients who attained a viral load of less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment. Edurant® in combination with other antiretroviral medicines was as effective as the comparator medicine at reducing the level of HIV-1 in the patients’ blood. Taking the two studies into account, 84% of patients taking Edurant responded to treatment after one year, compared with 82% of patients taking efavirenz.

* On May 20, 2011, the FDA approved Edurant® (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naïve). The safety and effectiveness of Edurant® is based on 48-week data from two Phase 3 clinical trials with 1,368 adult subjects with HIV infection, and from a 96-week (with extension to 192 weeks) trial. Patients had not received prior HIV therapy and were selected to receive treatment with Edurant® or efavirenz (another FDA-approved non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV infection). Both drugs were given in combination with other antiretroviral drugs. Edurant® was as effective as efavirenz in lowering viral load. In the Edurant® and efavirenz groups, 83 percent and 80 percent of subjects, respectively, had undetectable amounts of HIV in their blood after 48 weeks of treatment. Patients receiving Edurant® who had a higher viral load at the start of therapy were more likely not to respond to the drug than were patients with a lower viral load at the start of therapy. In addition, persons who failed therapy with Edurant® developed more drug resistance than patients who failed efavirenz. The most commonly reported side effects in patients taking Edurant included depression, difficulty sleeping (insomnia), headache and rash. Fewer patients stopped taking the drug due to side effects as compared to patients taking efavirenz.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2011-05-20

UE authorization: 2011-11-28/2015-11/20

Favourable opinion UE: 2011-09-22/2015-10-22

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes