FDA approves first two-drug HIV regimen in a single pill

The FDA yesterday approved the first two-drug regimen available in a single pill for the maintenance treatment of HIV.

The drug, Juluca, combines ViiV Healthcare‘s integrase strand transfer inhibitor and Janssen Therapeutics‘ non-nucleoside reverse transcriptase inhibitor.

The treatment is indicated for adults with HIV who are virologically suppressed on a stable anti-retroviral regimen for at least six months.

“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,” Deborah Waterhouse, CEO of Viiv Healthcare, said in prepared remarks.

“This is the start of a new era in HIV treatment. We are delighted to be able to provide the first two-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive life-long treatment for their chronic condition.”

“Today’s approval of Juluca marks a significant milestone in the treatment of HIV,” Brian Woodfall, global head of late development for Janssen’s R&D division, added.

“As the first single-pill, complete two-drug regimen, Juluca maintains the safety and efficacy of a traditional three-drug regimen without an N(t)RTI. This is exciting because it offers those living with HIV who are compliant and stably suppressed a new, simplified treatment option to consider.”

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