Three medicines treating HIV, pain and cancer have been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) at its latest meeting.
Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) was endorsed as a treatment HIV-1 infection.
The once-daily single tablet regimen has shown high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase III clinical trials involving treatment-naïve adult patients and among virologically suppressed adults who switched regimens.
The marketing application contains data from four Phase III studies in which the regimen met its primary goal of non-inferiority to ViiV Healthcare’s flagship drug dolutegravir (DTG) at 48 weeks.
The therapy was approved in the US in February.
The CHMP also recommended approval of one hybrid medicine, FGK Representative Service GmbH’s Dzuveo (sufentanil), for the treatment of pain.
Hybrid applications rely in part on the results of preclinical tests and clinical trials for a reference product and in part on new data.
The opioid produces analgesia by activating μ-opioid receptors primarily within the central nervous system, and its most common side effects are nausea, vomiting and pyrexia.
Elsewhere, the Committee voiced its support for Obvius Investment BV’s generic medicine Carmustine Obvius (carmustine), for the treatment brain tumours, non-Hodgkin’s lymphoma and Hodgkin’s disease.