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Rilpivirine and cabotegravir were approved for medical use in the European Union in December 2020, as two separate medications. [11] [12] In January 2021, the U.S. Food and Drug Administration (FDA) granted the approval of Cabenuva to ViiV Healthcare. [4] [8] The combination was approved for medical use in Australia in February 2021. [14] [15]
Cabotegravir in combination with rilpivirine is indicated for the treatment of human immunodeficiency virus type-1 (HIV-1) in adults. [1] [7] The combination injection is intended for maintenance treatment of adults who have undetectable HIV levels in the blood (viral load less than 50 copies/mL) with their current antiretroviral treatment, and when the virus has not developed resistance to ...
GSK Plc said on Monday that its HIV-focused unit ViiV Healthcare's cabotegravir injected drug and tablets got a positive opinion from the European Medicines Agency for marketing authorisation.
HPTN 083 is a 2016 clinical trial which compares cabotegravir injections with oral use of Emtricitabine/tenofovir as pre-exposure prophylaxis ("PrEP") for prevention of HIV/AIDS. The study seeks to test injectable PrEP as a way to remedy adherence for many patients on a daily pill regimen.
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
It was approved for use in 2018 in Australia, [8] the European Union [7] and the United States [9] and in 2019 in New Zealand [10] and the United Kingdom; [11] a generic version was approved by the Drugs Controller General of India in 2019. [1]
(Reuters) -The U.S. Food and Drug Administration on Tuesday approved Johnson & Johnson's chemotherapy-free combination treatment for a type of non-small cell lung cancer, setting up a challenge ...
Maraviroc, sold under the brand names Selzentry (US) and Celsentri (EU), is an antiretroviral medication used to treat HIV infection. [3] [4] It is taken by mouth. [3] [4] It is in the CCR5 receptor antagonist class. [3] [4] It was approved for medical use in the United States in August 2007, [3] and in the European Union in September 2007. [4]