FDA Approves First Injection Treatment for HIV

by TLM


On January 21, 2021, the FDA approved Cabenuva as an alternative to oral antiretroviral regimens taken daily to suppress HIV-1 in adult patients.

Cabenuva is the first extended-release injection for HIV and is administered once-monthly, which means that those who choose to switch can manage a chronic condition without taking medication daily. The drug is designed for HIV positive adults who are already virally suppressed with their daily oral regimen and have established tolerance of cabotegiavir and rilpivirine, oral versions of the active ingredients in Cabenuva taken for one month prior to the first injection. There are reported adverse reactions to Cabenuva: “injection sire reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.”

Cabenuva was approved after “two randomized, open-label, controlled clinical trials.” It was granted Fast Track and Priority Review by the FDA. Fast Track expedites the review of drugs related to the treatment of “serious conditions and [fulfillment] of an unmet medical need.” This is judged by the following factors: “survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one.” AIDS, Alzheimer’s, heart failure, cancer, epilepsy, depression, and diabetes are some examples of serious conditions that receive consideration for this process. Being approved for fast track requires being advantageous over available options of treatment or filling a current unmet need for treatment. Fast Track must be requested by the drug company and can require more ongoing communication with the FDA as the drug develops before, during, and after approval through a rolling review. This means that the drug company “[submits] completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA,” as opposed to submitting everything at one time for FDA review and approval.

The approval of this injection could introduce a huge time-saving change and ease of mind for those currently maintain viral suppression with daily medication.