FDA approves Trogarzo 90-second intravenous (IV) push loading dose for the treatment of HIV infection – Theratechnologies Inc

Theratechnologies Inc. announced that the FDA has approved the company’s Labelling Prior Approval Supplement to include a 2000-mg intravenous (IV) push loading dose for Trogarzo (ibalizumab-uiyk). IV push is a method by which the undiluted medication is “pushed” by syringe for faster administration into the body’s circulation and is designed to make Trogarzo administration easier and more convenient for people […]

Janssen submits supplemental new drug application to FDA seeking expanded pediatric indication for HIV-1 therapy Edurant

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication of Edurant (rilpivirine) to include the treatment of HIV-1 infection in children weighing 10 kg or more. A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support […]

Twice-yearly lenacapavir demonstrates sustained impact on health-related quality of life in people with HIV – Gilead Sciences

Gilead Sciences, Inc. presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including patient-reported outcomes (PRO) from the Phase II/III CAPELLA trial . These latest findings underscore the role of lenacapavir, the first long-acting injectable HIV treatment medication administered twice-yearly, as a person-centric therapy option and its transformative potential impact on the future of coordinated HIV clinical […]

Phase III CARISEL study of Vocabria + Rekambys shows long-acting regimen is achievable in HIV – ViiV Healthcare

ViiV Healthcare presented positive interim data from the Phase III CARISEL study of Vocabria + Rekambys (cabotegravir + rilpivirine), which was initiated and conducted during the COVID-19 pandemic. The study evaluated perspectives of healthcare teams and people living with HIV, through surveys and interviews, around the implementation of Vocabria (cabotegravir injection) and Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys […]

FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV – ViiV HealthCare

ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, has announced it has made a regulatory submission to the FDA for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine and, to extend its current approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower […]

FDA approves expanded indication of Biktarvy for treatment of HIV-1 in pediatric populations – Gilead Sciences

Gilead Sciences, Inc. announced the FDA approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy. The approval of this supplemental New Drug Application (sNDA) expands the indication for Biktarvy […]

ViiV Healthcare submits extended approval request for tablet formulation of Triumeq for HIV to FDA

ViiV Healthcare has announced it has made a regulatory submission to the FDA for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine and, to extend its current approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower the minimum weight at which a child can be prescribed this medicine, from 40kg and above […]