The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Juluca (ViiV Healthcare UK Ltd), a once-daily, fixed-dose combination of dolutegravir (50 mg) and rilpivirine (25 mg), for treatment of HIV-1 infection.
Dolutegravir is an integrase strand transfer inhibitor and rilpivirine (Janssen Sciences Ireland UC) is a non-nucleoside reverse transcriptase inhibitor.
The European Medicines Agency (EMA) committee backed Juluca for HIV-1-infected adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.
Juluca can “maintain viral suppression of HIV strains that lack resistance (documented or clinically suspected) to integrase inhibitors,” the EMA said in a news release.
In the SWORD-1 and SWORD-2 phase 3 studies published earlier this year in The Lancet , the dolutegravir/rilpivirine regimen was non-inferior to 3- or 4-drug regimens in maintaining virologic suppression through 48 weeks in adults who are infected with HIV-1 and have no history of resistance or treatment failure, in both pooled and individual analyses of the studies, the company notes in a press release. The most common side effects are insomnia, headache, dizziness, nausea and diarrhea.
The positive opinion from CHMP “takes us a step closer to offering the first, single-pill, 2-drug regimen with the opportunity to reduce the number of drugs needed to treat HIV in those who are virologically suppressed; Juluca is expected to be the smallest single-pill regimen in the market,” Deborah Waterhouse, chief executive officer at ViiV Healthcare, said in the release.
“We believe no one should have to take more medicines than they need, and dolutegravir/rilpivirine represents our first 2-drug regimen that could reduce the number of antiretrovirals people living with HIV in Europe take daily, whilst maintaining the efficacy of traditional three-drug regimens,” John Pottage, Jr, MD, chief scientific and medical officer, ViiV Healthcare, said in the release.
Detailed recommendations for the use of Juluca will be described in the summary of product characteristics, which will be published and made available in all official European Union languages after the European Commission (EC) grants marketing authorization.
The final EC decision on European approval for Juluca is anticipated towards the end of the second quarter of 2018, the company said.
Juluca was approved by the US Food and Drug Administration last November.
For more news, join us on Facebook and Twitter
Tidak ada komentar:
Posting Komentar