CHMP recommends extending the indication for Biktarvy to include children with HIV
The European Union drug regulator's human medicines committee has recommended a new dosage strength for Gilead Sciences' HIV drug Biktarvy and an extension of its indication
The Committee for Medicinal Products for Human Use (CHMP) recommended the addition of a new strength for Biktarvy as 30 mg/120 mg/15 mg film-coated tablets.
The CHMP also recommended extending the indication of the drug to be used as a treatment for HIV in children from two years of age. Accordingly, the full indication for Biktarvy as recommended by the CHMP would be for the treatment of HIV-1 infection in adults and pediatric patients at least 2 years of age and weighing at least 14 kg without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
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