Once-Daily Single-Tablet Complera For HIV-1 Infection Approved By FDA

Editor's Choice
Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 10 Aug 2011 - 17:00 PDT


The US FDA has approved Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), a once-a-day single tablet for patients with HIV-1 infection who are new to treatment (treatment-naïve patients), makers and marketers Gilead Sciences Inc. announced today.

Complera contains three antiretroviral drugs in one tablet:

• Truvada - a Gilead medication, a fixed-dose combination of two medications, emtricitabine and tenofovir disoproxil fumarate. Approved by the FDA in August 2004.
• Edurant (rilpivirine) - a Tibotec Pharmaceuticals drug which is marketed in the USA by Janssen Products LP. Approved by the FDA in May 2011.

Tony Mills, MD, Director of Medical Research, Anthony Mills MD, Inc. and a participating investigator in ongoing Complera studies, said:

"In the 30 years since the first AIDS cases were reported, we've made incredible strides in the treatment of this disease. The concept of a single-tablet regimen has become a goal in HIV drug development, and the standard of care in medical practice in the United States. However, no one therapy is appropriate for all patients.

Given its efficacy, safety and convenience, the availability of Complera represents an exciting milestone in addressing the individual needs of patients new to HIV therapy."

Complera's approval is supported by data from two Phase III active controlled, double-blind, randomized studies carried out by Tibotec. The ECHO and THRIVE trials evaluated rilpivirine compared to efavirenz for efficacy and safety among HIV-1 infected adults who had not received medications before.

John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences, said:

"Complera is the second complete single-tablet regimen that Gilead has introduced, and it represents a collaboration between two organizations that share a vision of simplifying HIV therapy for patients. Tremendous progress has been made in the field of HIV, but we recognize new therapies are still needed, and we continue to work to advance options that address the needs of patients."

Gilead wrote that Complera is the second complete antiretroviral treatment regimen for treatment-naïve HIV-1 patients in a single pill that is taken once a day. The first was Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), which is marketed by Bristol-Myers Squibb and Gilead.

Gilead will manufacture, develop and market Complera in the USA, European Union, New Zealand, Australia, Canada and Brazil. Tibotec is allowed to co-market the drug in those areas. Tibotec will be responsible for the manufacture, development and marketing in other areas.

The FDA initially rejected Gilead's submission for approval of Complera in January, citing insufficient data. Gilead says it has resolved all issues cited in an FDA warning letter, which expressed concerns regarding manufacturing problems and product quality at the San Dimas, California plant.

Written by Christian Nordqvist


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