FDA OKs Gilead's Pediatric HIV Treatment and Boehringer's Humira Biosimilar


The U.S. Food and Drug Administration greenlit a new indication for Gilead Sciences' drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.

The latest approval for Biktarvy expands the indication to include younger HIV-1 patients. Gilead Sciences believes the expanded endorsement will close the gap between available treatments for adults and pediatric patients. 

Pediatric HIV patients "are in need of effective and accessible formulations of antiretroviral therapy," Merdad Parsey, Gilead’s chief medical officer, said. “To address this unmet need, innovations in pediatric formulations must strive towards expanding treatment options for children. The sNDA approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world.” 

Approval for Biktarvy for children weighing at least 14 kg is based on data from Cohort 3 of a Phase II/III study that found low-dose tablets of the medication were effective through 24 weeks in virologically suppressed children living with HIV-1. After 24 weeks, 91% of the HIV-infected children remained virologically suppressed. 

In 2018, Gilead originally won the approval of Biktarvy, a triple combination treatment of bictegravir and emtricitabine/tenofovir alafenamide for the treatment of HIV-1.

The approval comes almost four months after the world marked a grim milestone of 40 years since HIV was realized. The virus has taken the lives of an estimated 35 million people over the last 40 years. 

It is estimated there are about 3 million people under the age of 19 infected with HIV across the globe. In 2020, around 120,000 children and adolescents died from AIDS-related causes. About 72% of these mostly preventable deaths occurred among children under 10 years old. 

In addition to the FDA's expanded approval for Gilead’s HIV drug, the regulatory agency also greenlit Boehringer Ingelheim's Biologics License Application for Cyltezo (adalimumab-adbm). The approval makes the BI drug the first Interchangeable biosimilar with AbbVie’s Humira (adalimumab).

The FDA initially approved Cyltezo in 2017 for the treatment of multiple chronic inflammatory diseases. The latest approval from the regulatory agency designated the biosimilar as an interchangeable treatment across all of these indications. Although it has been approved for multiple indications in the U.S., Cyltezo is not yet commercially available. The biosimilar will not be available until July 1, 2023, due to patents protecting AbbVie’s Humira. 

In 2019, the Boehringer Ingelheim and AbbVie resolved patent litigation regarding Cyltezo. AbbVie claimed that Boehringer Ingelheim prepared to launch Cyltezo ahead of the expiration of its Humira patents. AbbVie also insisted that Boehringer Ingelheim was stockpiling its biosimilar ahead of its launch.

Thomas Seck, senior vice president of Medicine and Regulatory Affairs at Boehringer Ingelheim, noted that the Interchangeability status of Cyltezo reinforces the company’s goal of expanding overall treatment options for the U.S. market. A biosimilar with an Interchangeable designation can be auto-substituted by a pharmacist for the branded treatment.

According to Boehringer Ingelheim press release, "the approval for Interchangeability was supported by positive data from Boehringer Ingelheim's Phase III VOLTAIRE-X trial that studied the effects of multiple switches between Humira and Cyltezo. This additional study demonstrated that Cyltezo is equivalent to Humira with no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity, and safety between the switching and continuous treatment groups." It marks the first FDA approval for such a study.

Back to news