CORK, Ireland, September 23, 2011 /PRNewswire/ --
- Third HIV medication submitted by Tibotec -
Tibotec Pharmaceuticals (Tibotec), one of the Janssen Pharmaceutical Companies, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of EDURANT® (rilpivirine), a 25 mg tablet, as a once-daily treatment in combination with other antiretroviral agents (ARVs), for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with a viral load ≤ 100,000 HIV-1 RNA copies/mL. Rilpivirine is a medicinal product in the non-nucleoside reverse transcriptase inhibitor (NNRTI) class.
The positive opinion is based on 48-week analyses of ECHO and THRIVE, two phase 3 clinical trials which evaluated the efficacy, safety and tolerability of rilpivirine in more than 1,350 treatment-naïve HIV-1 adult patients in over 20 countries. The 48-week analyses of both ECHO and THRIVE were published in the 16th July 2011 edition of the Lancet[1,2].
"We are committed to developing new and innovative treatment options for HIV, especially those which improve patients' lives by simplifying treatment regimens and improving adherence. If approved, rilpivirine will offer a further option for patients who are starting HIV combination therapy for the first time," says Wim Parys, MD, Global Head, Infectious Diseases, Janssen. "Rilpivirine is an important part of Janssen's HIV portfolio which also includes PREZISTA® (darunavir) and INTELENCE® (etravirine). We are encouraged by this positive opinion from the CHMP and will work closely with regulatory authorities to make rilpivirine available to HIV patients in Europe."
Rilpivirine is also combined with Gilead's TRUVADA® (emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) in a once-daily single-tablet regimen, which was submitted under a separate Marketing Authorisation Application (MAA) and is currently under assessment by the EMA.
Parys added: "We are pleased to partner with Gilead, one of the leading companies in the fight against HIV/AIDS, which shares our dedication to improving treatment options for people living with HIV."
The CHMP positive opinion is a critical step in the approval process and will be considered by the European Commission, which has authority to approve medicines for use throughout the European Union. Rilpivirine was approved by the U.S. Food and Drug Administration (FDA) in May 2011 and by the Canadian Health authorities (Health Canada) in July 2011. Applications for approval have also been submitted in other countries, including Switzerland and Australia. A fixed dose combination of rilpivirine and Gilead's TRUVADA® (emtricitabine 200mg/tenofovir disoproxil fumarate 300mg), was also approved by the U.S. FDA in August 2011.
About EDURANT® (rilpivirine)
Rilpivirine is an investigational NNRTI, which blocks reverse transcriptase, a key enzyme that the HIV virus uses to replicate. The regulatory application for rilpivirine is based on the 48-week results of two pivotal Phase 3 double-blind, randomized studies known as ECHO (TMC278-C209) and THRIVE (TMC278-C215).[1,2] The studies evaluated the efficacy, safety and tolerability of once-daily rilpivirine, in combination with two NRTIs, in treatment-naïve HIV-1-infected adults, and both achieved their primary objective of demonstrating non-inferiority of rilpivirine vs. efavirenz in the percentage of patients achieving an undetectable viral load (less than 50 copies/mL) at week 48.[1,2]
The percentage of adverse events (AEs) leading to discontinuation with rilpivirine or efavirenz, regardless of severity, was 2 percent and 4 percent, respectively. The most common AEs leading to discontinuation in the rilpivirine arm vs. the efavirenz arm included psychiatric disorders (1 percent vs. 2 percent) and rash (0.1 percent vs. 1.5 percent). Other AEs to rilpivirine (incidence > 2 percent) of at least moderate-to-severe intensity (> Grade 2) were depressive disorders (4 percent), insomnia (3 percent), headache (3 percent) and rash (3 percent).
Tibotec Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global pharmaceutical and research development company. The Company's main research and development facilities are in Beerse, Belgium with offices in Titusville, NJ and Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS and hepatitis C drugs, and anti-infectives for diseases of high unmet medical need.
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases.
Driven by our commitment to patients, Janssen develops innovative products, services and healthcare solutions to help people throughout the world.
More information 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. 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 Tibotec Pharmaceuticals, any of the other Janssen Pharmaceutical Companies and/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. The Janssen Pharmaceutical Companies and Johnson & Johnson do not undertake to update any forward-looking statements as a result of new information or future events or developments.
- Molina J-M et al. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet. 2011; 378: 238-246.
- Cohen C et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet. 2011; 378: 229-237.
SOURCE Tibotec Pharmaceuticals