Janssen Seeks to Expand Indication for Rilpivirine to Include Children Weighing 10 Kg or More With HIV-1

Janssen has submitted a supplemental New Drug Application (sNDA) to the FDA requesting an expanded indication for rilpivirine (Edurant), according to a company press release. The expanded indication will include treatment for HIV type 1 (HIV-1) infection in children who weigh 10 kg or more.

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“We’ve been working to fight HIV for decades and are proud to have helped bring forward 9 medicines for people living with HIV,” said Global Therapeutic Area Head Penny Heaton, MD, Infectious Diseases and Vaccines, Janssen Research & Development, LLC, in the press release.

Janssen also submitted a marketing authorization application to the European Medicines Agency (EMA) asking that the agency expand rilpivirine’s indication for pediatric use. With FDA and EMA approval, rilpivirine would be administered as a standard 25 mg tablet or 2.5 mg tablet. The 2.5 mg oral tablet is Janssen’s effort to have weight-adjusted dosing available for this patient population.

The phase 2 PAINT (NCT00799864) trial was a pivotal study that evaluated long-acting rilpivirine with other antiretroviral therapies for pediatric patients weighing 10 kg or more who are virologically suppressed and treatment-experienced (with HIV-1 RNA below 50 copies/mL). The PICTURE (NCT04012931) study evaluated rilpivirine for pediatric patients weighing 10 kg or more and who are treatment-naïve, with HIV-1 RNA less than or equal to 100,000 copies/mL.

Both trials suggest that rilpivirine is effective at maintaining or suppressing HIV-1, leading to the expansion of rilpivirine’s indication for pediatric patients. Its efficacy remains limited to patients with HIV-1 RNA less than or equal to 100,000 copies/mL compared to those with HIV-1 RNA above 100,000 copies/mL.

The most common adverse events (AEs) associated with rilpivirine treatment are depression, headache, trouble sleeping (insomnia), and rash. Severe AEs are rash and allergic reaction alongside fever, tiredness, difficulty breathing, skin swelling, joint ache, and redness. Janssen also cautions that this medication should not be taken with anti-seizure, anti-tuberculosis, or proton pump inhibitor medications.

Long-acting rilpivirine is FDA-approved as part of a combination regimen with long-acting cabotegravir (Vocabria; Viiv Healthcare). This is the first ever short-term long-acting injectable HIV-1 treatment option for children aged 12 years and older.

The indication includes adolescents aged 12 years and older and weighing 35 kg minimum, along with adults who are virologically suppressed on antiretroviral therapy and no history of treatment failure. The current indication requires at least 6 treatments per year.

“These filings are the latest example of our longstanding work to make different treatment options available to meet the diverse needs of people living with HIV,” Heaton said in the press release.

Reference

Janssen Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Pediatric Indication for HIV-1 Therapy EDURANT®. The Janssen Pharmaceutical Companies of Johnson & Johnson. News Release. July 28, 2023. Accessed on August 1, 2023. https://www.janssen.com/janssen-submits-supplemental-new-drug-application-us-fda-seeking-expanded-pediatric-indication-hiv-1