Regulators in the European Union have given the green light to a once-daily single tablet version of Johnson & Johnson's HIV blockbuster Prezista.
The European Commission has approved Prezista (darunavir) 800mg allowing people living with HIV to take one tablet instead of two 400mg pills (approved in 2007) once a day. The drug is always taken in combination with ritonavir and other HIV drugs, together with food.
Brian Woodfall, head of medical affairs at J&J's Janssen EMEA unit, said that "strict adherence to treatment regimens is crucial to prevent virological failure and the development of drug resistance when treating HIV". He added that the approval means "we are providing an alternative solution and a reduced pill burden which should make it easier for patients to manage their treatment on a day-by-day basis and keep their HIV at undetectable levels".
J&J says there are 34.5 million people living with HIV globally, with 2.5 million people becoming newly infected each year. Thanks to significant advances in treatment over the past 30 years, "a diagnosis for these people is no longer a death sentence," the healthcare giant says, but data shows that after eight months of treatment only 65% of patients will achieve 100% compliance".
The 800mg tablet was approved by the US Food and Drug Administration in November 2012. The agency had issued a complete response letter for the protease inhibitor six months earlier but had not requested additional trials.