British drugmaker GSK said on Wednesday its long-acting injectable HIV therapy showed promise in keeping the viral load suppressed compared to daily oral treatment, especially in individuals facing challenges with pill intake. The interim analysis of a late-stage trial on the therapy known as Cabenuva demonstrated superior efficacy in maintaining viral load suppression compared to daily oral therapy in individuals with a history of adherence challenges to oral antiretroviral treatment, which is used to suppress and mitigate the progression of the disease. The lack of consistent adherence is a common reason why some people living with HIV struggle to keep the virus in check, GSK said.
The approval for Pfizer's (PFE) Velsipity (etrasimod) is based on data from two pivotal phase III studies, ELEVATE UC 52 and ELEVATE 12.
Pfizer's drug to treat patients with an inflammatory bowel disease called ulcerative colitis has been approved by the European Commission, the company said on Monday. The approval for Velsipity follows backing from the European Medicines Agency's panel of experts in December. The drug was approved for use in patients aged 16 or older and who did not show adequate response or were intolerant to previous treatment, Pfizer said.