Monthly HIV medication hits roadblock as FDA knocks back approval

The US Food and Drug Administration (FDA) has knocked back new HIV medication Cabenuva, declining to add it to the list of approved medications in the USA.

The new medication is a once a month treatment for people living with HIV, rather than the regime of daily pill taking. The treatment sees patients receiving two injections once a month at a doctor’s surgery.

Cabotegravir which stops the HIV virus from infecting human cells and Rilpivirine which blocks the virus from making copies of itself.

The manufacturer behind the new treatment, Viiv Healthcare, say the rejection from the FDA is disappointing, but they will submit their application again after they have addressed the authorities concerns.

“Clearly this is disappointing and not the news we hoped for,” said a spokesperson from ViiV Healthcare, manufacturers of the drug, in an email to US news agency ABC.

The FDA’s decision to decline approval was related to concerns about the manufacturing and control process, not the safety or efficacy of the drug.

Doctors who treat people living with HIV say the new treatment option will be a game-changer for people who have the virus. It will also mean that people who have HIV will no longer be required to carry medication with them when they travel overseas, which can at times cause problems.

The new medication has already passed a series of clinical trials to prove it’s effectiveness. As the FDA’s rejection is not related to the effectiveness of the drug, no further trials will be required before a new submission is lodged.

Want to stay up to date with the latest HIV news, head to the WA AIDS Council.

OIP Staff

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