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.
The approval of Cabenuva (cabotegravir and rilpivirine, injectable formulation) means HIV infected adults could receive once-monthly injections to manage their condition.
Despite high hopes for its game-changing monthly HIV regimen Cabenuva, GlaxoSmithKline's ViiV Healthcare went back to the drawing board after the FDA slammed the drug's manufacturing late last year. But Canadian regulators had few concerns and now Cabenuva will be ready for launch in its first global market.
Teva Pharmaceutical Europe BV an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the National Institute for Health and Care Excellence (NICE) has recommended AJOVY (fremanezumab) in its Final Appraisal Document (FAD) for the prevention of migraine in adults with chronic migraine. NICE recommends AJOVY® for chronic migraine patients who have not responded to at least three prior preventive drug treatments.
HIV patients will have to wait a while longer for a long-acting viral suppression regimen as the FDA has rejected ViiV Healthcare’s NDA for the monthly injection of cabotegravir and rilpivirine.
GlaxoSmithKline’s ViiV Healthcare division has announced plans to develop an investigational broadly neutralising antibody (bNAb) N6LS for the treatment and prevention of HIV-1.