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ViiV Requests FDA Approval for Dolutegravir Single-tablet Regimen for HIV

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ViiV Healthcare announced this week that it has submitted a New Drug Application for U.S. Food and Drug Administration (FDA) approval of a new all-in-1 pill containing the HIV integrase inhibitor dolutegravir (brand name Tivicay) plus abacavir and lamivudine (the drugs in Epzicom).

Approval of dolutegravir was based in part on favorable results from 2 randomized controlled trials of treatment-naive people: SINGLE, which tested dolutegravir plus abacavir/lamivudine against Atripla (efavirenz/tenofovir/emtricitabine single-tablet regimen), and SPRING-2, comparing dolutegravir against raltegravir (Isentress), both with either abacavir/lamivudine or tenofovir/emtricitabine (the drugs in Truvada). The more recent FLAMINGO trial showed that dolutegravir also worked better than ritonavir-boosted darunavir (Prezista) for first-line therapy.

For treatment experienced patients, the Phase 3 SAILING trial showed that dolutegravir demonstrated better efficacy than raltegravir with fewer discontinuations due to virological failure and less emergent drug resistance. The VIKING trials demonstrated that dolutegravir is effective against HIV that has developed resistance to multiple classes of other antiretrovirals.

If approved, the new coformulation will offer the first 1 pill/once-daily regimen that does not contain tenofovir/emtricitabine, the NRTI backbone in the 3 currently marketed single-tablet regimens, Gilead Science's Atripla, Complera (rilpivirine/tenofovir/emtricitabine) and Stribild (elvitegravir/cobicistat/tenofovir/emtricitabine). It may offer an attractive option particularly for people with or at risk for kidney disease or osteoporosis, as tenofovir can cause kidney toxicity and bone loss.

Below is an edited excerpt from the recent ViiV press release describing the regulatory submission.

ViiV Healthcare Announces US Regulatory Submission for a Single-tablet Regimen Combining Dolutegravir with Abacavir and Lamivudine for People Living with HIV

London, UK -- October 22, 2013 -- ViiV Healthcare today announced the submission of a regulatory application in the United States for its investigational single-tablet regimen (STR) combining dolutegravir, abacavir and lamivudine for the treatment of people living with HIV-1. This New Drug Application (NDA) follows the approval of dolutegravir by the US Food and Drug Administration (FDA) in August 2013 under the brand name Tivicay, approved for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40 kg (approx. 88 lbs).

"People living with HIV and their doctors seek to use appropriate treatment options for the individual, while also trying to minimize the number of pills required for effective and acceptable antiretroviral treatment," said Dr. John Pottage, Chief Medical Officer, ViiV Healthcare. "This submission aims to make a complete Tivicay-based regimen available for the first time in a single once-daily pill."

In Europe, a Marketing Authorization Application (MAA) for this single-tablet regimen will be submitted in the near future. The review of the MAA for dolutegravir (DTG), submitted in Europe in December 2012, is in progress with the European Medicines Agency (EMA). A combination tablet containing abacavir (ABC) and lamivudine (3TC) is approved and available in the US under the brand name Epzicom (abacavir sulfate 600 mg + lamivudine 300 mg) and in the EU under the brand name Kivexa.

The investigational single-tablet combination of DTG/ABC/3TC has sometimes been referred to as "Trii." The submission announced today is based on data from one pivotal Phase III study of DTG, supported by three other Phase III/IIIb studies, which evaluated the safety and efficacy of this regimen. It additionally includes pivotal data evaluating the bioequivalence of DTG/ABC/3TC when taken as a single-tablet regimen compared to the administration of DTG with ABC/3TC as separate components. A further 48-week Phase IIIb/IV study of this single-tablet regimen in treatment-naive HIV-positive women (the ARIA study) is ongoing.

See the full release online for references and important safety information about dolutegravir and Epzicom.

Prescribing information for Tivicay is available online at: https://www.viivhealthcare.com/media/58599/us_tivicay.pdf  

Prescribing information for Epzicom is available online at: https://www.viivhealthcare.com/media/70430/us_epzicom.pdf 

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a 10% shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

10/25/13

Source

ViiV Healthcare. ViiV Healthcare Announces US Regulatory Submission for a Single-tablet Regimen Combining Dolutegravir with Abacavir and Lamivudine for People Living with HIV. Press release. October 22, 2013.