The National Medical Products Administration (NMPA) has approved the market application for GlaxoSmithKline’s (GSK, NYSE: GSK) Juluca (dolutegravir/rilpivirine), a dual therapy for adult patients infected with human immunodeficiency virus type 1 (HIV-1). This approval marks a significant milestone, as Juluca is the first dual therapy approved by the FDA for the maintenance treatment of patients with virological suppression.
Dual Therapy and Its Advantages
Juluca is a combination of dolutegravir, an HIV-1 integrase chain transfer inhibitor (INSTI) that prevents the virus from entering cells, and rilpivirine, an oral non-nucleoside reverse transcriptase inhibitor (NNRTI). Compared to traditional HIV therapies that include at least three drugs, Juluca is expected to reduce toxicity for patients while maintaining effective viral suppression.
Clinical Trial Results
The safety and efficacy of Juluca were evaluated in the SWORD 1 and SWORD 2 studies, which enrolled a total of 1,024 subjects whose viral infection was effectively controlled by conventional three-drug or four-drug anti-HIV therapies. Participants were randomly assigned to either continue their conventional therapy or switch to dolutegravir/rilpivirine. The results showed that the combination therapy effectively inhibited the HIV virus, achieving outcomes comparable to those of conventional therapy.
Regulatory Timeline
Juluca was first approved in the US in November 2017 and was filed for marketing in China in January of the previous year. The drug was subsequently granted priority review status by the NMPA, highlighting its potential to address the needs of HIV-1 patients in China.
Future Outlook
The approval of Juluca by the NMPA underscores the ongoing commitment of GSK and ViiV Healthcare to bring innovative and effective treatments to patients with HIV-1. This dual therapy offers a new option for maintaining viral suppression with potentially fewer side effects, enhancing the quality of life for patients.-Fineline Info & Tech
