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Bristol-Myers Squibb receives approval for Reyataz label update
Bristol-Myers Squibb's HIV therapy Reyataz has received European approval for a new labelling update, following a recent clinical study.
The European Commission has ratified the company's decision to include new dosing and medical guidance on the Reyataz packaging for HIV-affected women during pregnancy or just after birth.
It follows the conclusion of the pharmokinetic study AI424-182 to evaluate the safety and efficacy of the drug among this patient group, which is estimated to include around three million women worldwide on an annual basis.
According to European AIDS Clinical Society guidelines, the changes in the body that accompany pregnancy make it essential for optimum dosages of HIV therapies to be administered.
Margaret Johnson, clinical director of HIV services at the Royal Free NHS Trust in London, said: "This labelling update is important news for both physicians and women with HIV of child-bearing age in that it provides dosing and medical guidance for the use of Reyataz/ritonavir during pregnancy and postpartum."
Earlier this month, Bristol-Myers Squibb and Pfizer received a recommendation from the National Institute for Health and Clinical Excellence for their new venous thromboembolism treatment Eliquis.
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