The FDA Expands Use for Gilead Science’s HBV Treatment

The United States Food and Drug Administration (FDA) approved the supplemental new drug application (sNDA) for Gilead Science’s Vemlidy® (tenofovir alafenamide). Vemlidy received prior approval as a treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. 

The sNDA approved on November 2 expands use to pediatric patients 12 years of age and older with compensated liver disease. The basis of the sNDA is the results from the Phase 2 1092 clinical trial.

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Expanding Use to Pediatric Patients

Vemlidy is a treatment for chronic HBV infection. The treatment incorporates itself into the virus’ DNA, where it then prevents HBV replication. 

On November 10, 2016, the FDA granted Vemlidy’s first approval. At the time, the basis of the approval was two international Phase 3 studies (Studies 108 and 110). The studies met both of their primary endpoints, demonstrating non-inferiority to Viread based on the percentage of patients with chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy. The FDA’s decision then granted approval for treatment in adults.

Gilead sought further approval for their HBV treatment, initiating the Phase 2 1092 trial. The trial randomized 70 treatment-naïve and treatment-experienced patients between the ages of 12 to less than 18 years with either Vemlidy or a placebo. The trial met its primary endpoint, demonstrating that Vemlidy patients showed HBV DNA <20 IU/mL at 24 weeks compared to the 0% the placebo showed. 

As a result, Gilead submitted an sNDA which the FDA approved on November 2. 

On the approval, Merdad Parsey, MD, PhD, Chief Medical Officer of Gilead Sciences, said, “With an established safety profile and once-daily dosing, Vemlidy provides physicians a new option to address the treatment needs of pediatric patients living with hepatitis B.”

The approval marks another win for Gilead’s HBV treatment. Currently, it is unknown if Gilead intends further testing with a Phase 3 trial.

Author

Max Heirich