Drugmaker Laurus Labs on September 14 said that it has entered into an agreement with global health agency Unitaid and the Clinton Health Access Initiative (CHAI) to accelerate the development, commercialisation, and registration of the second and third-line HIV treatment darunavir boosted with ritonavir (DRV/r) for children.
Laurus will be provided with a financial incentive for a portion of its development and commercialisation costs. CHAI will work closely with Laurus Labs to provide technical and regulatory support to enable accelerated generic development and regulatory submission of the medication.
The product development collaboration between Unitaid, CHAI, and Laurus Labs was spearheaded through Unitaid’s investment in CHAI since 2016 to bring the best HIV medications to market more quickly and integrate them into treatment programmes in low- and middle-income countries that need them the most.
Despite being available in high-income countries for more than 15 years, a generic, fixed-dose combination pediatric version of DRV/r is still not available.
The drug which is a best-in-class protease inhibitor has been shown to effectively treat HIV in children who are just beginning treatment, or whose treatment is no longer working.
The WHO-led Pediatric Antiretroviral Drug Optimisation (PADO) group, which establishes and reviews priorities for drug development for pediatric HIV treatment and prevention, lists pediatric DRV/r 120/20mg as a priority formulation to provide robust treatment for second- and third-line use after failure on DTG-based regimens. Despite being listed as a PADO priority since 2013, a pediatric version of DRV/r has not yet been developed.
Second- and third-line therapies are critical for CLHIV where the World Health Organization (WHO)-recommended first-line treatment dolutegravir (DTG) may not be an option due to medication resistance or intolerance. Currently, available second and third-line treatments are often difficult for children to take due to bitter taste and difficult forms of administration.
"This agreement is a welcome step towards having a long-awaited pediatric formulation of DRV/r available, as we strive to achieve the global goal of 90 percent of people living with HIV receiving antiretroviral therapy,” said Unitaid Executive Director Philippe Duneton.
“A pediatric version of DRV/r has been a global health priority since 2013, but is still not available, leaving thousands of children without the lifesaving medication they need,” said Ann Veneman, interim Co-CEO of CHAI.
“We are excited about this innovative mechanism to accelerate the availability of pDRV/r regimen for children living with HIV," said Satyanarayana Chava, Founder & CEO, Laurus Labs.
"The collaboration between Laurus Labs, CHAI, and Unitaid can positively impact over 100,000 CLHIVs and help them in leading a better life especially in their formative years,” Chava noted.