The U. S. Food and Drug Administration on Friday approved a product that is based on a maternal herpes virus infection cleared by treatment with naltrexone hydrochloride. The milestone comes as a recent trial of naltrexone, a medication used to treat opioid use disorder, was deemed too risky by authorities.
In a move that may change the way naltrexone is used across the US, the FDA affirmed approval of Tellex®, a 6-dose/month regimen approved by the US (and other countries) for helping mothers with HIV/AIDS enter pregnancy. It also approved the company’s use in women who have HIV and are considering giving birth.
Tellex is based on the Maternal Hygiene Virus and Pediatric Pineal Carcinogenic Virus (MH-CVC) RR/T-cell therapy, which was approved by the US in 2008 for using cells from HIV patients with no HIV infection to treat newborn babies with HIV. The FDA approved the use of the HHV-CVC-RR/T cell coupled receptor B (HCRBB) approach in CYP2C19 (cell type overactive in HIV-resistant T cells) and HIV-infected immunocompromised patients on canagliflozin, an antiretroviral therapy. The company is developing its own antibody vaccine candidate that is being developed based on the HHV antigen.
The earlier approval of Tellex mimics the current game-changing work that the agency concluded was done to cede ground to the startup of Eli Lilly and Co, the only pharmacist-approved product qualified by the FDA to use for its medical management. The timing of the HHV approval of Tellex is significant because HIV patients frequently try antiviral drugs and surgeries, and many do not have access to highly qualified and FDA-approved therapy.
“Our regulatory and pharmacoepidemiological research has resulted in an understanding that approved medications including naltrexone should hold a low premuned indication while they are used for ordinary nonmedical purposes in patients who are HIV positive or who are monogamous”said Dr. Janet Silverman, President and Chief Executive Officer of Third-Amity (the non-profit communications arm of ZiON, Inc. of Sunnyvale, California)