US FDA approves GSK’s HIV drug for patients with limited options

The US Food and Drug Administration approved GlaxoSmithKline’s HIV drug, Rukobia, to treat adult patients who have run out of treatment options.

The oral treatment from the company’s HIV unit, ViiV Healthcare, has been approved for adults whose HIV infection could not be successfully treated with other therapies due to resistance, intolerance or safety considerations, the agency said.

Antiretroviral medicines suppress HIV and help in decreasing disease progression, HIV transmission, and AIDS-related deaths. However, HIV has the ability to constantly change and can lead to some individuals developing viral resistance, causing their treatment regimens to fail.

The most common adverse reactions from the drug, taken twice daily, were nausea, fatigue and diarrhea.

Pfizer and Shionogi hold small stakes in ViiV Healthcare.