Artesunate intravenous injection approved in the U.S.

The U.SFood and Drug Administration (FDA) recently approved Amivas' artesunate for injection, an artesunate for injection, to treat severe malaria in adults and childrenThe drug was approved through the priority review process and was previously granted the status of the orphan drugit's worth noting that artemisinin amber iv preparations are the only FDA-approved drugs in the U.Sto treat severe malariaIt is important to note that when treating severe malaria with intravenous (IV) artemisinin, follow-up treatment should always be treated with a full course of oral antimalarial treatmentPrior to this approval, artemisinin-based ethnolipid IV preparations could only be made available to patients through the FDA's expanded access program, which allows the U.SCenters for Disease Control and Prevention (CDC) to provide artemisinin IV preparations to U.Spatients with severe malaria and simple malaria patients who cannot take oral drugs under the experimental new drug (IND) programThe U.Shas not had an FDA-approved drug to treat severe malaria since producers stopped selling quinidine in March 2019"This approval will now give patients more access to life-saving drugs," said DrJohn Farley, acting director of the Infectious Diseases Office at the FDA's Center for Drug Evaluation and ResearchIn addition, the risk of developing into severe malaria underscores the importance of taking drugs to prevent malaria and use mosquito avoidance measures when travelling to malaria-endemic areas"
About 2,000 cases of malaria are diagnosed in the United States each year, with 300 of them suffering from serious diseases, according to the CDCIn the United States, most people diagnosed with malaria are infected during travel to malaria countries Malaria is a parasitic disease transmitted by mosquito bites Malaria patients often develop fever, chills, and flu-like illnesses, and if not properly treated, they can experience serious complications such as kidney failure, seizures, insanity, coma and death a randomized controlled trial in Asia (trial 1) and a supportive randomized controlled trial in Africa (trial 2) initially evaluated the safety and effectiveness of artemisinin IV preparations for the treatment of severe malaria 1 in the trial, 1 patients were enrolled in 1,461 patients receiving artemisinin IV preparations or the controlled drug quinine, including 202 children aged 15 years The trial 2 included 5,425 randomized pediatric patients aged 15 with severe malaria who received artemisinin or quinin In these two trials, the number of deaths in hospitals among patients treated with artemisinin was significantly lower than in the control group treated with Quinin In trial 1, the most common adverse reactions in malaria patients treated with artemisinin IV were acute renal failure, hemoglobinuria and jaundice requiring dialysis The safety of test 2 is basically similar to that of Test 1 note that artemisinin cannot be used in patients who are known to be severely allergic to artemisinin