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Application for HIV drug submitted to EMA


An application has been sent to the European Medicines Agency (EMA) for TMC278 to be approved for the treatment of adults with HIV infection, following a successful study in Rome, Italy.

Tibotec Pharmaceuticals, one of the Janssen Pharmaceutical Companies, announced today 96-week findings from two pivotal Phase 3 clinical trials, known as ECHO and THRIVE, comparing the efficacy, safety and virology profile of its investigational, non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus efavirenz (EFV).

The pooled analysis at 96 weeks showed that 77.6% of patients achieved and sustained an undetectable viral load (less than 50 copies/mL) while taking TMC278 as part of combination therapy. These findings were presented today at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Rome, Italy.

Pooled ECHO and THRIVE results for TMC278 and EFV, each administered once daily with a nucleoside/nucleotide background regimen in treatment-naïve, HIV-1-infected adults, showed that 77.6% of patients in both the TMC278 arm (n=686) and the EFV arm (n=682) reached an undetectable viral load at 96 weeks.  These long-term data demonstrated non-inferiority of TMC278 vs. EFV in this population at 96 weeks, consistent with the 48-week primary analysis. Patients taking TMC278 had a virologic failure rate of 14% compared to 7.6% experienced by patients taking EFV, of which 3.2% and 2.3% occurred in the second year of treatment, respectively.

“Finding safe and tolerable regimens over an extended period of time is critically important in HIV care, and it is encouraging to see that the long-term data for TMC278 remain consistent with what we have seen previously,” said Professor Jean-Michel Molina from Saint-Louis Hospital in Paris, France.

“These data suggest TMC278 may provide a welcome new option for treatment-naïve patients and their physicians.”

Adverse events (AEs) leading to discontinuation in the TMC278 arm were 4% compared to 9% in the EFV arm, and there were no new safety concerns with either NNRTI between 48 and 96 weeks.   The most common AEs of interest (pre-specified) reported in the TMC278 arm vs. the EFV arm included dizziness (8% vs. 27%), abnormal dreams/nightmares (8% vs. 13%), and rashes (4% vs. 15%).  The incidence of Grade 2-4 AEs at least possibly related to treatment over at least 96 weeks was 17% in the TMC278 arm vs. 33% in the EFV arm.  Grade 3-4 lipid abnormality increases were also observed among patients in the TMC278 arm versus the EFV arm in total cholesterol (0.1% vs. 3%), LDL-cholesterol (1% vs. 5%) and triglycerides (0.6% vs. 3%).

TMC278 was approved in May 2011 by the US Food and Drug Administration (FDA) in combination with other antiretroviral (ARV) medications for treatment of adults with HIV infection who are new to ARV therapy and will be marketed in the US as EDURANTTM.  An application for approval has also been submitted to the European Medicines Agency and elsewhere, including Canada, Switzerland and Australia. TMC278 is the third anti-HIV medication to be developed by Tibotec Pharmaceuticals.

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