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Last week, the FDA denied the approval of Cabenuva, the first of its kind monthly HIV injection treatment. Developers hoped that the monthly injection would replace daily pills, thus making life easier for HIV patients and also possibly removing some of the stigma associated with the disease.
According to ABC News, the FDA had no concerns with the drug’s efficacy or safety. Rather the application’s denial was due to concerns regarding the drug’s manufacturing process. In their Complete Response Letter (CRL) regarding the New Drug Application, the FDA stated their rejection was related to “Chemistry, Manufacturing, and Controls (CMC),” EMPR reported.
Cabenuva passed trials and proved to be effective at repressing virus levels in HIV-positive patients. New trials will not be required as the FDA denial was not related to concerns with drug safety. Instead, the manufacturers plan to “work closely and with urgency with the FDA to determine the appropriate next steps for this new drug application,” a drug spokesperson told ABC News.
“Clearly this is disappointing and not the news we hoped for,” said a spokesperson.
HIV is a virus that weakens a person’s immune system by interfering with their ability to fight off infection. Although there is no cure, there are certain medications that can help control the disease by slowing the virus’ progression in the body. These drugs may also aid in lowering an individual’s risk of spreading HIV to others by reducing the amount of the virus in your body, the Center for Disease Control and Prevention report.
The Cabenuva injection contains two active ingredients (cabotegravir and Janssen’s rilpivirine). The long-lasting drug is administered every four weeks. For some HIV patients there is a fear of stigma associated with their health status. Release from the dependence of daily pills may save some from this stigma.
In addition to HIV treatment, there are also medications used called PrEP (Pre-Exposure Prophylaxis), which help prevent HIV negative individuals from contracting the virus. The combination of these HIV prevention and treatment medications have helped to slow the rate of HIV transmission in the U.S. and improve the lives of those living with the virus.
Although the FDA cited that there were no concerns with the safety of Cabenuva, doctors express concerns of may come along with a monthly injection versus a daily pill. For example, patients who miss an injection may be at greater risk for the virus to grow in numbers and strength, ABC News reported.
The drug application was filed by ViiC Healthcare, which is majority-owned by GlaxoSmithKine. Pfizer and Shionogi also have small stakes.