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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.
Rilpivirine, sold under the brand name Edurant among others, is a medication, developed by Tibotec, used for the treatment of HIV/AIDS. [6] [7] It is a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) with higher potency, longer half-life and reduced side-effect profile compared with older NNRTIs such as efavirenz.
In the judgment delivered on 1 December 2020, which has now been overturned on appeal, the judges said that it was highly unlikely that a child aged 13 or under would be competent enough to give consent to puberty blockers, and that it was doubtful that 14 or 15 year olds could understand the long-term risks and consequences associated with ...
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 ...
Lenacapavir was approved for medical treatment in the European Union in August 2022, [10] [12] in Canada in November 2022, [5] [6] and in the United States in December 2022. [9] [11] [13] [14] It is the first of a class of drugs called capsid inhibitors to be approved by the US Food and Drug Administration (FDA) for treating HIV/AIDS. [11] [15]
As Novo Nordisk and Eli Lilly expand sales of their popular diabetes and weight-loss drugs, cheaper copies of their patented remedies are winning approval from some regulators overseas, posing a ...