Janssen Submits New Drug Application for Rilpivirine Injection to Treat HIV-1 in China

By |Pharmaceutical Insights

Today (November 4), according to a public notice from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), Janssen, a Johnson & Johnson company, has submitted a marketing authorization application for a new HIV medication, rilpivirine injection, which has been accepted for review. Previously, rilpivirine tablets were approved in China for use in combination with other antiretroviral agents to treat human immunodeficiency virus type 1 (HIV-1) infection in adults.

Screenshot source: CDE Official Website

According to an early press release by Janssen, rilpivirine is a low-dose (25 mg) oral non-nucleoside reverse transcriptase inhibitor (NNRTI) characterized by proven efficacy and favorable safety and tolerability. In 2017, rilpivirine tablets were approved in China, indicated for the treatment of HIV-1 infection in treatment-naive patients aged 12 years and older with a baseline HIV-1 RNA level of ≤100,000 copies/mL at the initiation of therapy.

It is worth mentioning that researchers have also explored "cocktail therapies" combining rilpivirine with other HIV treatments, several of which have already received regulatory approval. Examples include the two-drug HIV regimen Dovato, the triple-combination HIV tablet Odefsey, and the long-acting injectable HIV therapy Cabenuva.

Among them, Cabenuva is an injectable formulation composed of rilpivirine and cabotegravir. Publicly available data indicate that it is the world's first complete, long-acting treatment regimen capable of effectively suppressing HIV-1 with just once-monthly injections. It reduces the number of days patients require treatment annually from 365 to 12. Currently, Cabenuva has been approved for marketing in multiple countries worldwide and is indicated as a complete regimen for the treatment of adult patients with HIV-1 infection who are virologically suppressed on antiretroviral therapy.

According to the CDE public announcement, Janssen Pharmaceuticals has submitted a marketing authorization application for the injectable formulation of rilpivirine. It is hoped that this formulation will be approved soon, bringing new treatment options to more patients.

References:

[1] Center for Drug Evaluation, National Medical Products Administration. Retrieved Nov. 04, 2021, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV. Retrieved January 21, 2021, from https://www.prnewswire.com/news-releases/fda-approves-first-extended-release-injectable-drug-regimen-for-adults-living-with-hiv-301212892.html

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