Laurus Labs is developing a generic, fixed-dose combination of paediatric version of darunavir boosted with ritonavir (DRV/r) for use as second- and third-line treatment of HIV.
This follows an agreement Unitaid, Clinton Health Access Initiative (CHAI) and the company entered into in June to accelerate the development, commercialisation and registration of a best-in-class second- and third-line HIV treatment. A generic, fixed-dose combination paediatric version is not available though DRV/r has been available in high-income countries for over 15 years.
Under the programme, Laurus will be provided with a financial incentive for a portion of its development and commercialisation costs. CHAI will work with it to provide technical and regulatory support to enable accelerated generic development and regulatory submission of the medication, the drugmaker said in a release on Tuesday.
Interim co-CEO of CHAI Ann Veneman said “a paediatric version of DRV/r has been a global health priority since 2013, but is still not available. The innovative incentive programme announced today will enable development of an effective paediatric medication that will save the lives of children living with HIV.”
Second- and third-line therapies are critical for children living with HIV where the World Health Organization-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, the company said.
Laurus Labs founder and CEO Satyanarayana Chava said the collaboration between the company, CHAI, and Unitaid can positively impact over 100,000 CLHIVs.
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