U.S. FDA Approves Streamlined Process for Initiating HIV Therapy with Cabenuva

On Thursday, ViiV Healthcare and Janssen Pharmaceutical‘s treatment for people living with human immunodeficiency virus (HIV-1) received a label update to now include injectable administration.

The U.S. Food and Drug Administration approved adding the option for Cabenuva (cabotegravir and rilpivirine) to be used as a once-monthly or once every two months injectable therapy without requiring patients to first go through an oral lead-in period. Previously, patients had to take daily cabotegravir and rilpivirine tablets one month before the injectable version can be given. 

The health regulator’s decision is based on positive clinical data pointing to the efficacy and safety of the drug regardless of whether the patient has undergone or not undergone an oral lead-in phase. Week 124 results from the FLAIR (First Long-Acting Injectable Regimen) showed similar outcomes in terms of safety, tolerability, virologic suppression and pharmacokinetics in both patient groups. 

Cabenuva is a combination of integrase strand transfer inhibitor cabotegravir, made by ViiV Healthcare, and a non-nucleoside reverse transcriptase inhibitor rilpivirine, made by Janssen. The latter is approved in the U.S. to be taken once daily to treat HIV-1 in combination with other antiretroviral agents for patients ages 12 years and up who have a viral load of less than or equal to 100,000 HIV RNA c/ml and weigh at least 35 kgs. 

“With this expanded label milestone, Janssen is offering an additional pathway that simplifies the treatment landscape for people living with HIV in the U.S. who are prescribed Cabenuva therapy. We have a proven track record of bringing innovative therapies to people living with HIV, and our commitment to ushering in new scientific advancements has not wavered,” commented James Merson, Ph.D., the global therapeutic area head for infectious diseases at Janssen Research & Development, in a statement. 

“Providing a diverse portfolio of HIV therapies is critical to help meet these various treatment needs, and we believe Cabenuva is a meaningful option for the patients and providers we serve,” noted Candice Long, the president of infectious diseases and vaccines arm of Janssen Therapeutics, in the same announcement.

Source: BioSpace

Cabenuva is the first and only complete long-acting HIV treatment regimen for HIV-1 patients who have no known or suspected resistance to either drug’s components and no history of treatment failure. It is not advised for patients who are taking phenytoin, rifabutin, carbamazepine, phenobarbital, oxcarbazepine, rifampin, system dexamethasone, rifapentine and St. John’s wort. Common adverse reactions include headache, pyrexia, nausea, dizziness, sleep disorders, fatigue, rash and musculoskeletal pain. 

It was first approved in 2021 for use once monthly to reduce the frequency of taking antiretroviral treatments from once a day to just 12 times a year. The FDA gave its go signal to use Cabenuva once every two months as an injectable in February 2022.

The once-monthly injectable is already approved by Health Canada, the European Commission, the Swiss Agency for Therapeutic Products and the Australia Therapeutic Goods Administration. The every-two-months injectable has the approval of the European Commission, Swiss Agency for Therapeutic Products and Health Canada. 

More regulatory reviews and submissions in other locations are underway throughout 2022.