A once-a-day HIV medication that combines two different drugs has moved a step closer after testing them in combination showed they worked well together.
The study discovered Gilead Sciences Inc’s Truvada and an experimental drug from Johnson & Johnson-owned Tibotec Pharmaceuticals can work together with no interference.
Two Phase III studies of Tibotec’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg) have met the primary efficacy objective and the company said its submission of TMC278 to the US Food and Drug Administration for regulatory review is on track for the third quarter of this year.
The drug prevents a key enzyme of the AIDS virus from converting its RNA to DNA and stops the virus from infecting cells.
California-based Gilead is expected to submit its application for the combined once-a-day, fixed-dose pill to the FDA soon after Tibotec’s own new drug application is approved..
The bioequivalence study that the combination medicine has undergone is a requirement of the FDA and was successful in demonstrating that a co-formulated product achieves the same levels of medication in the blood as occurs when the individual products are dosed simultaneously as separate pills.
The combination pill would make life easier for HIV patients, who often have to take a cocktail of several drugs to fight off the virus.
Truvada is itself a combination of Gilead’s Viread and Emtriva HIV treatments that was introduced in August 2004.
Copyright Press Association 2010