Rilpivirine, the non-nucleoside reverse transcriptase inhibitor in development by Tibotec, a Johnson & Johnson company, has proved non-inferior to efavirenz in two phase III trials, the company revealed today.
The product met the primary objective laid down for the two phase III studies designed to provide data for licensing of the new antiretroviral drug, showing no significant difference in the proportion of previously untreated patients with viral load below 50 copies/ml after 48 weeks of treatment when compared to efavirenz.
Johnson & Johnson said that rilpivirine will be submitted for US Food and Drug Administration approval in the third quarter of 2010.
The third and most definitive stage in the clinical evaluation of a new drug or intervention, typically a randomised control trial with the new intervention compared to an existing therapy or a placebo, in large numbers of participants (typically hundreds or thousands). Trial results are used to evaluate the overall risks and benefits of the drug and provide the information needed for regulatory approval.
A clinical trial which aims to demonstrate that a new treatment is not worse than another. While the two drugs may have comparable results in terms of virological response, the new drug may have fewer side-effects, be cheaper or have other advantages.
A retroviral enzyme which converts genetic material from RNA into DNA, an essential step in the lifecycle of HIV. Several classes of anti-HIV drugs interfere with this stage of HIV’s life cycle: nucleoside reverse transcriptase inhibitors and nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.
Results from the two phase III studies will be presented at an international scientific conference later this year, and the studies will continue to follow patients to 96 weeks.
Gilead Sciences, which is partnering with Tibotec in the development of a fixed-dose, once-daily tablet combining its drugs tenofovir and emtricitabine with rilpivirine, said today that it was still working on the development of a coformulation that would supply bioequivalent levels of the three drugs when dosed in one tablet.
Earlier this year Decision Resources issued an analysis of pharmaceutical resources predicting that a combination tablet could generate revenues of around $2 billion per year for the two companies by 2018.
