FDA Expands Indication of Long-Acting Injectable HIV Treatment

April 06, 2022 - FDA recently expanded the indication of the long-acting injectable HIV regimen, Cabenuva, to include virologically suppressed adolescents 12 years of age and older. 

Johnson & Johnson and ViiV Healthcare co-developed Cabenuva (cabotegravir and rilpivirine). Cabotegravir is an investigational drug currently being studied to treat and prevent HIV infection, while rilpivirine reduces the enzyme activity in HIV-infected cells. 

FDA approved Cabenuva as the first and only complete long-acting HIV-1 treatment regimen in January 2021 based on trial results which showed that 1,182 virologically suppressed HIV-positive adults continued to show virologic suppression with Cabenuva use.   

The expanded approval includes eligible adolescents with no history of treatment failure. Providers can administer the drug to patients once a month or every two months.  

“HIV remains one of the most significant challenges in global health, and as part of our decades-long commitment to fighting HIV, Janssen is working tirelessly to advance innovative new treatment options for young people living with HIV,” James Merson, PhD, global therapeutic area head of infectious diseases at Janssen Research & Development, said in the announcement.  

“With this milestone, we’re continuing to redefine how HIV can be managed so that even more people, including adolescents, can benefit from long-acting injectable therapies,” Merson continued.  

In 2020, there were approximately 37.7 million people across the globe with HIV. Of these people, 36 million were adults and 1.7 million were children aged up to 14 years of age.  

FDA based its expanded indication for Cabenuva on studies in adults and children. Researchers confirmed that Cabenuva was safe and well-tolerated with a safety profile consistent with cabotegravir plus rilpivirine in all trials.  

FDA Approves Novo Nordisk’s Ozempic for Type 2 Diabetes  

FDA recently approved Novo Nordisk’s semaglutide injection, Ozempic, to treat adults with type 2 diabetes.  

Ozempic is now approved in the US for 0.5, 1.0, and 2.0 mg doses. The drug also reduces the risk of major cardiovascular events, including heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.  

“We are pleased with the FDA approval for a higher 2.0 mg dose of Ozempic®, which further supports our purpose of driving change in diabetes care,” Martin Lange, executive vice president of development at Novo Nordisk, said in the announcement.  

“The approval of the 2.0 mg dose allows more people with type 2 diabetes to achieve and maintain individualized glycaemic targets and remain on the same medication for longer as their needs evolve,” Lange continued.  

FDA based its approval on results from the SUSTAIN FORTE trial. In the trial, individuals achieved a statistically significant and superior reduction in HbA1c at week 40 compared to 1.0 mg of semaglutide. Notably, both doses of semaglutide had a safe and well-tolerated profile.  

Novo Nordisk expects to launch Cabenuva in the second quarter of 2022.  

FDA Approves Seizure Treatment  

FDA recently approved Ztalmy to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two years of age and older.  

CDD is a rare developmental epileptic encephalopathy caused by the CDKL5 gene. Patients with CDD generally have infantile-onset epilepsy that doesn’t respond to currently available treatment options, FDA stated.  

Ztalmy is the first treatment for seizures associated with CDD and specifically for CDD.  

FDA based the approval on results from a randomized, double-blind clinical trial in patients 2–19 years of age. All patients in the trial had confirmed CDKL5 gene mutation, seizures inadequately controlled by at least two previous treatment regimens, and a minimum average of 16 major motor seizures per 28 days two months before screening.  

Participants treated with Ztalmy saw a 31% median reduction in the 28-day frequency of significant motor seizures versus a 7% reduction in patients who received a placebo.