New Type of HIV Rx Approved

FDA approves Rukobia (fostemsavir) to treat HIV

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new type of HIV medication.

This new approval is for Rukobia (fostemsavir). The FDA approved it to treat adults who have HIV — specifically those who have already tried several HIV medications without success because they could not tolerate the side effects or there were resistance or safety issues.

“This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options,” said Dr. Jeff Murray, deputy director of the FDA's Division of Antivirals, in a press release.

This medication is available in extended-release tablet form and is to be taken twice daily by mouth, with or without food.

"As a novel HIV attachment inhibitor, fostemsavir targets the first step of the viral lifecycle offering a new mechanism of action to treat people living with HIV," said Dr. Jacob P. Lalezari, chief executive officer and director of Quest Clinical Research, in a press release from the drug manufacturer.

A common side effect of Rukobia is nausea. This medication can lead to severe side effects, including high levels of liver enzymes. This issue was seen with those who were also infected with hepatitis B or C virus.

Another possible severe side effect includes a change in the immune system called immune reconstitution syndrome.

The FDA granted approval of this medication to ViiV Healthcare.