Artesunate intravenous injection approved in the U.S.

MAY 28 (UPI) -- THE U.SFOOD AND DRUG ADMINISTRATION (FDA) RECENTLY APPROVED AMIVAS INC.'S ARTESUNATE FOR INJECTION, A TREATMENT FOR 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 preparationist is the only FDA-approved drug 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 enabled the U.SCenter son ofControl and Prevention (CDC) to provide artemisinin IV preparations to Patients 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, director of the infectious diseasesat 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, and 300 of them have serious illnesses, according to the CDC In 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 efficacy of artemisinin IV preparations for the treatment of severe malaria trial 1 included 1,461 patients receiving artemisinin IV preparations or the controlled drug quinine, including 202 patients aged 15 The trial 2 included 5,425 randomized pediatric patients aged 15 years with severe malaria who received artemisinin or quinin In both trials, the number of deaths in of artemisinin-treated patients was significantly lower than in the control group treated with quinin The most common of malaria patients treated with artemisinin IV in trial 1 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.