FDA Approves Janssen's Edurant PED for HIV-1 Treatment in Pediatric Patients Aged 2 Years and Older

FDA Approves Johnson & Johnson's Edurant (Rilpivirine) PED Oral Suspension Tablets for Use with Other Antiretroviral Therapies (ART) to Expand Its Indication to Treat Antiretroviral Treatment-Naïve Children Aged 2 Years and Older Weighing Between 14 kg and 25 kg (HIV-1 RNA <100,000 copies/mL)Edurant (Rilpivirine) is a non-nucleoside reverse transcriptase inhibitor specific to HIV-1, which has previously been approved for use in combination with ART to treat HIV-naive patients aged 12 years and older, weighing at least 35 kg.The new approval criterion this time is RNA less than or equal to 100,000 copies/mL.

"Decades of global AIDS epidemic experience have shown that providing new and improved treatment options for people living with HIV from different populations is crucial," said Dr. Penny Heaton, Head of Infectious Diseases and Global Therapeutics. In a press release from Johnson & Johnson, she stated, "Although the number of children infected with HIV is relatively small, offering additional treatment options remains essential to ensure every person living with HIV receives a regimen suitable for them."

This regulatory action is based on the results of the PAINT (NCT00799864) and PICTURE (NCT04012931) trials conducted in pediatric patients. The key Phase II PAINT trial analyzed the use of long-acting Edurant in combination with other ART therapies in pediatric patients weighing more than 10 kg, who were virologically suppressed and undergoing treatment (HIV-1 RNA below 50 copies/mL). The Phase II PICTURE trial evaluated the use of Edurant in treatment-naïve pediatric patients weighing more than 10 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.

These trials found that,This combination effectively suppresses HIV infection in treatment-naïve pediatric patients (HIV-1 RNA < 100,000 copies/mL). Patients aged at least 2 years and weighing at least 25 kilograms can safely take either the standard Edurant 25 mg oral tablet or the newly approved Edurant PED 2.5 mg oral tablet, which have been developed for convenient pediatric dosing and weight-based dose adjustment.

According to the report,The most common adverse events associated with Edurant include depression, headache, insomnia, and rash. The most common serious adverse events associated with Edurant include rash and allergic reactions, as well as fever, fatigue, difficulty breathing, skin swelling, joint pain, and redness. Additionally, the manufacturer warns that Edurant should not be used in conjunction with antiepileptic drugs, antituberculosis drugs, or proton pump inhibitors.

Patients with epilepsy should not take Edurant, nor should it be used in combination with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, dexamethasone (single dose exceeding), St. John's Wort, esomeprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole.

Long-Acting Edurant is the first approved short-term, long-acting injectable HIV-1 treatment regimen for children aged 12 years and older. It was previously approved in combination with Vocabria (cabotegravir) for the short-term treatment of HIV-1 infected patients aged 12 years and older, weighing at least 35 kg, and virologically suppressed (HIV-1 RNA less than 50 copies/mL). This indication includes patients aged 12 years and older, weighing at least 35 kg, as well as adults who are virologically suppressed on ART and have no history of treatment failure.