December 23, 2019
2 min read

FDA declines to approve long-acting HIV treatment

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The FDA has declined to approve a long-acting HIV treatment that patients would be able to receive as a monthly injection, but not over safety concerns, according to the two manufacturers that developed the investigational regimen.

In a complete response letter (CRL), the FDA cited reasons related to “chemistry, manufacturing and controls (CMC),” Janssen Pharmaceuticals and ViiV Healthcare reported. The companies said there have been no reported CMC-related safety issues and that the CRL does not relate to the regimen’s clinical safety data that was submitted to the FDA.

Two phase 3 trials demonstrated that the monthly injectable regimen of cabotegravir (ViiV) and rilpivirine (Janssen) was noninferior to daily oral therapy and overwhelmingly preferred by patients, according to data presented earlier this year at CROI.

"We believe the once-monthly, long-acting regimen represents an important therapeutic advance for those living with HIV," Brian Woodfall, MD, Janssen’s global head of development for infectious diseases, said in a statement. "We will continue to collaborate with our partners and the FDA to fully understand the requirements needed to support U.S. approval as we continue in our efforts to change the course of the HIV epidemic."

Further study findings publicized more recently suggested that the regimen — called Cabenuva — remains effective when given every 2 months.

Paul E. Sax

In a online post for NEJM Journal Watch, Paul E. Sax, MD, clinical director of the HIV program and division of infectious diseases at Brigham and Women’s Hospital in Boston and professor of medicine at Harvard Medical School, said it was “reassuring” that the FDA review did not raise any additional safety concerns. He said “most people (including me)” expected that the regimen would win FDA approval.

“HIV clinicians and our patients will need to wait a bit longer for approval of this regimen,” Sax wrote. “Until we hear more details, we won’t know how long. But the data from clinical trials are solid enough that approval should be forthcoming eventually.” – by Gerard Gallagher


Janssen. Complete response letter issued from U.S. FDA for investigational long-acting HIV regimen. Accessed December 23, 2019.

NEJM Journal Watch. HIV and ID Observations: FDA defers approval for first long-acting HIV therapy, surprising everyone. Accessed December 23, 2019.

Disclosures: Sax reports being a consultant or serving on an advisory board for Gilead Sciences, GlaxoSmithKline/ViiV, Janssen and Merck and receiving grant support from the NIH, Gilead and Merck. Woodfall is employed by Janssen.