ViiV Healthcare and Janssen Sciences Ireland UC’s Juluca Combination Tablets for treating HIV (type 1) was approved by the Ministry of Health, Labour and Welfare (MHLW), the company said Monday.
Juluca is a two-drug regimen of dolutegravir and rilpivirine, developed by Janssen Sciences Ireland UC, part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
ViiV said that the distribution and sales operations of the once-daily single-pill regimen will be conducted by GlaxoSmithKline K.K. Tokyo, in the same way as for existing products of ViiV Healthcare in Japan.
Dustin Haines, President, ViiV Healthcare, Japan said: “This regulatory approval demonstrates our commitment to bringing new medicines for people living with HIV, as they now have the opportunity to maintain their viral suppression with only two drugs within a single-pill.”
The drug was filed for approval in Japan in August 2018, In the USA in November 2017, and in May 2018 in Europe.
Dr. Ichiro Koga, MD, Director Medical Affairs, ViiV Healthcare, Japan said: “We have found a way to reduce the number of antiretrovirals whilst maintaining the efficacy of the traditional three-drug regimen, for people living with HIV. This innovative advancement supports our commitment to making HIV treatment a smaller part of people’s lives and demonstrates the potential of our robust clinical research programme.”