JDC Gems

1. FDA approves NDA of Hydroxychloroquine to address COVID-19

Hydroxychloroquine (HCQ) is a promising drug candidate in the treatment of diabetes. Researches on the potential benefits of HCQ in treating diabetes provides ample evidences on improvement of lipid profile and insulin levels and substantial diminution of HbA1c, fasting plasma glucose, and postprandial blood glucose levels in patients remarkably. In addition, reduction in lysosomal degradation of the internal insulin-insulin receptor complex and enhancement in insulin sensitivity and adiponectin levels are some of the hypothesized mechanisms for the antidiabetic effect of HCQ.

      The FDA recently has approved an abbreviated new drug application for Hydroxychloroquine sulfate tablets to address ongoing shortages of the drug sparked by its still unproven potential as a COVID-19 treatment modality. Despite the current lack of enough clinical trial results, the surge for treatment modalities to tackle the viral disease with high mortality rates worldwide had prompted the testing and use of the HCQ as a preventive care against COVID-19. Followed by this, on March 28, the FDA issued an Emergency Use Authorization (EUA), which allowed hydroxychloroquine and chloroquine products to be distributed and used for adolescent and adult patients hospitalized with COVID-19 who cannot be part of a clinical trial. The drugs have been provided for possible use in treating patients hospitalized with COVID-19, or for use in clinical trials, the SNS department said. Hydroxychloroquine sulfate must be administered orally. The suggested dose under this EUA for hydroxychloroquine sulfate to treat adults and adolescents who weigh 50 kg or more and are hospitalized with COVID-19 is 800 milligrams of hydroxychloroquine sulfate on the first day of treatment and then 400 milligrams daily for four to seven days of total treatment based on clinical evaluation.

      Hydroxychloroquine sulfate is contraindicated in the presence of retinal or visual field changes of any etiology and in patients with known hypersensitivity to 4-aminoquinoline compounds. Hydroxychloroquine sulfate should not be used in patients with a prolonged QT interval at baseline or at increased risk for arrythmia. Recommended Laboratory and Monitoring Procedures include a baseline electrocardiogram to assess for QT interval prolongation and other abnormalities. Baseline evaluation of renal and hepatic function is recommended. FDA issued this EUA, on the request by the Biomedical Advanced Research and Development Authority (BARDA).

      In addition to the EUA by FDA, the WHO launched an international clinical trial, the SOLIDARITY trial to test the efficacy of hydroxychloroquine (HCQ) and chloroquine in preventing COVID-19.

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