ViiV Healthcare to announce data from largest head-to-head randomised clinical trial for 2-drug regimen Dovato against 3-drug regimen Biktarvy at AIDS 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has on 3rd May, 2024 approved two new formulations of the medicine cabotegravir (Apretude 30 mg film-coated tablets and Apretude 600 mg prolonged-release suspension for injection) to help prevent sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35kg who are at an increased risk of infection. Cabotegravir has been authorised as tablets and as a long-acting injection administered every two months.
ViiV Healthcare Announces Data at CROI Indicating Efficacy of Cabenuva
GSK`s new HIV drug formula could support longer dosing intervals
GSK`s injectable HIV drug shows promise over daily pills
ViiV Healthcare receives approval from China’s NMPA for Vocabria
Sept 19 (Reuters) - The European Commission has authorised GSK's (GSK.L) HIV-focused unit ViiV Healthcare's cabotegravir long-acting injectable and tablets, the British drugmaker said on Tuesday.
As GSK’s ViiV Healthcare looks to widen the reach of its HIV franchise, Médecins Sans Frontières (MSF) has been working to secure access to the company's long-acting HIV prevention drug, Apretude, for more than a year.
GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, welcomed a positive opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for cabotegravir long-acting (LA) injectable and tablets for HIV prevention. Cabotegravir is recommended in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents weighing at least 35 kg.
GSK’s Cabenuva made history in 2020 as the world’s first complete, long-acting HIV regimen. But the injectable drug is approved in various countries only as a switch therapy for patients who already have undetectable HIV levels in the blood.