US regulators have approved GlaxoSmithKline’s (GSK) once-daily, single two-drug-tablet HIV drug Dovato following extensive testing of the product across more than 1,400 HIV patients. The drug is currently under review by the European Medicines Agency (EMA), as well as regulatory authorities in Canada, Australia, Switzerland, and South Africa, with several other submissions planned this year.
Dovato is the first two-drug regimen to be approved for use in HIV positive patients without a treatment history. Currently, HIV patients with no treatment history are subject to a three-drug regimen, but this simpler medicine means patients are not subject to additional toxicity and potential interactions from a third drug. Dovato marks GSK’s second two-drug regimen product following the approval of Juluca, which is currently used in HIV patients who have previously received treatment.
Broker Shore Capital believes two-drug HIV regimens are "a key growth driver" for GSK’s HIV product portfolio, although analysts are keen to see how physicians respond to the new product given the "well-established three-drug paradigm that currently exists within HIV medicine". They also admit that more data is required around possible resistance rates to two-drug regimens.
