The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended three medications for approval during its April meeting.
The treatments proposed include Gilead’s HIV-1 treatment Biktarvy, AcelRx Pharmaceuticals ’ hybrid pain therapy Dzuveo (sufentanil), and Obvius Investment’s Carmustine Obvius (carmustine), a generic treatment for brain tumours, non-Hodgkin’s lymphoma and Hodgkin’s disease.
CHMP is to consider a marketing authorisation for all three treatments.
Biktarvy is a once-daily single tablet regimen containing three active substances: bictegravir, emtricitabine and tenofovir alafenamide.
The drug has previously demonstrated efficacy in virologic suppression and no treatment-emergent resistance in Phase III trials. The marketing application contains data from four Phase III studies where the drug reached its primary goal of non-inferiority to ViiV Healthcare’s flagship drug dolutegravir (DTG) at 48 weeks. The drug was approved in the US in February.
The hybrid medication Dzuveo received a positive opinion for pain treatment, though the success of its application will be reliant on the results of preclinical tests and clinical trials due to its hybrid status. The drug, which has been authorised in the EU since 1978, is an opioid which produces analgesia through activating μ-opioid receptors within the central nervous system. Its most common adverse effects include nausea, vomiting and pyrexia.
Carmustine Obvius is a generic of the cancer medication Carmubris, which has been authorised in the EU since July 1996. The drug prevents DNA replication and transcription by alkylating reactive sites on nucleoproteins. As the generic is administered intravenously and is 100% bioavailable, CHMP does not require a bioequivalence study against the original Carmubris.
The EMA also announced its decision to re-examine the applications for Dexxience (betrixaban), Alsitek (masitinib) and Eladynos (abaloparatide), which received negative responses during the March 2018 meeting. These are treatments intended for venous thromboembolism, amyotrophic lateral sclerosis (ALS) and osteoporosis, respectively.
An initial marketing authorisation for Prohippur (sodium benzoate) was withdrawn following the April meeting. This was intended to be a treatment for non-ketotic hyperglycinaemia and urea cycle disorders. Similarly, an application for the extension of the use of Qtern (saxagliptin/dapagliflozin) in patients with type 2 diabetes was withdrawn.