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On World AIDS Day Tuesday, Unitaid and Clinton Health Access Initiative released astatementabout the drug and announced a pricing agreement to make it available in low- and middle-income countries.

“The 10 mg scored dispersible tablet was developed by Viatris (Mylan) and Macleods based on the technical information provided by ViiV Healthcare,” Clinton Health Access Initiative spokeswoman Regan Lachapelle said in an email.

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In low- and middle-income countries, the pediatric formulation of dolutegravir will cost about $36 per child per year, based on the pricing agreement brokered by Unitaid and Clinton Health Access Initiative with generic manufacturers Viatris and Macleods.

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“If infants get treated and their virus stays suppressed or controlled, they can live into their 3rd, 4th or perhaps even 5th decade of life—or longer,” Dr. Deborah Persaud, a professor of pediatrics at Johns Hopkins University and an expert in HIV/AIDS in children, told 【 - Free Investment Risk Control 】.

“Even if they are on treatment, for many years they have been on suboptimal drugs, because it always takes longer to develop and approve medications for children compared to adults,” Dr. Martina Penazzato, the HIV lead at the World Health Organization, told 【 - Free Investment Risk Control 】.

Penazzato said the formulation of pediatric dolutegravir could be “quite transformative” in the fight against pediatric HIV.

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ViiV Healthcare’s pediatric dolutegravir received US Food and Drug Administration approval in June, and the generic product received tentative approval on November 19 under the US President’s Emergency Plan for AIDS Relief (PEPFAR).

“This is the first time a generic product has been positively reviewed within several months of the originator product receiving FDA approval, reducing the gap from three years for the adult version of the same medicine to just five months,” Unitaid and Clinton Health Access Initiative wrote.

“FDA tentative approval via the President’s Emergency Plan for AIDS Relief (PEPFAR) program allows procurement of the product by US agencies such as PEPFAR, USAID,” Lachapelle said in an email.

“Each generic company is also in the process of registering the products within the countries where it will be used.”

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