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Juluca Provides 'Complete' Regimen for HIV.

LONDON -- ViiV Healthcare has been granted Food and Drug Administration approval for Juluca, a combination therapy indicated as a complete regimen for treating HIV-1 infection.

ViiV said Juluca is the first two-drug regimen comprising dolutegravir 50 mg, an integrase strand transfer inhibitor, and rilpivirine 25 mg, a non-nucleoside reverse transcriptase inhibitor from Janssen Therapeutics.

Specifically, Juluca is approved for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per ml) on a stable antiretroviral (ART) regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the medication's individual components.

"The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care. This is the start of a new era in HIV treatment," stated Deborah Waterhouse, chief executive officer ViiV Healthcare. "We are delighted to be able to provide the first two-drug regimen to physicians and people living with HIV in the U.S. to support the reduction of long-term ART exposure as they receive lifelong treatment for their chronic condition."

The FDA noted that the Juluca regimen involves just two medications rather than the three or more drugs included in standard HIV treatment.

"Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients," explained Debra Bimkrant, director of the division of antiviral products in the FDA's Center for Drug Evaluation and Research.

Viiv said that Juluca is the first medicine in its two-drug regimen pipeline, which aims to help lessen the lifetime burden of treatment for people living with HIV. The company noted that it's exploring the potential of two other two-drug regimens, both in Phase III development: a once daily, single dolutegravir/lamivudine pill for treatment-naive patients, and a cabotegravir/rilpivirine long-acting injectable for treatment-experienced and naive patients.

There is no cure for HIV, but effective treatment can control the virus. Improved access to antiretroviral treatment led to a 22% drop in global HIV mortality between 2009 and 2013, but more can be done for the estimated 36.7 million people living with HIV and 1.8 million individuals newly infected each year worldwide, according to research cited by Viiv.

"Based on the fundamental principle that no one should have to take more medicines than necessary, ViiV Healthcare has put in place a comprehensive two-drug regimen research and development program built around the characteristics of dolutegravir," commented John Pottage, chief scientific and medical officer for ViiV. "Juluca, our new two-drug regimen, once-daily, single pill, now provides people living with HIV who are virologically suppressed the option to reduce the number of anti-retrovirals they take while maintaining the efficacy of a traditional three-drug regimen."

ViiV Healthcare and Janssen Sciences Ireland UC, a Janssen Pharmaceutical-Johnson & Johnson company, announced a partnership in June 2014 to investigate the potential of combining dolutegravir and rilpivirine in a single tablet to expand the treatment options for people with HIV.

ViiV is majority-owned by GlaxoSmithKline PLC, and Pfizer Inc. and Shionogi Ltd. are shareholders of ViiV.
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Title Annotation:RX/Branded Drugs
Publication:Chain Drug Review
Date:Dec 11, 2017
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