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The Food and Drug Administration (FDA) has approved Artesunate for Injection (Amivas) for the initial treatment of severe malaria in adult and pediatric patients.
Artesunate and its metabolite DHA are both active against the blood-stage asexual parasites and gametocytes of Plasmodium species including the chloroquine resistant strains. The treatment, however, is not active against the hypnozoite liver stage forms of P. vivax and P. ovale. Concomitant therapy with an antimalarial agent such as an 8-aminoquinoline drug is necessary to treat severe malaria due to P. vivax or P. ovale.
The approval was based on data from multiple clinical trials. The first trial, conducted in Southeast Asia, included 1461 hospitalized adult and pediatric patients with severe malaria. Patients were randomized to receive intravenous (IV) artesunate or IV quinine until oral therapy could be started. Results showed that the in-hospital mortality rate in the artesunate group was significantly lower than the rate in the quinine group (13% vs 21%, respectively; odds ratio: 0.59 [95% CI, 0.44-0.79]).
Additionally, data from a published international, randomized, open-label trial comparing parenteral artesunate to parenteral quinine in pediatric patients with severe malaria (N=5425) in 9 African countries supported the efficacy of the treatment. Similar results were observed in this study, indicating an advantage with artesunate with respect to in-hospital mortality.
The treatment was also assessed in 102 US patients with severe or complicated malaria who were supplied artesunate under the Centers for Disease Control and Prevention (CDC) expanded access protocol. Among the 92 patients who were administered treatment, 7 patients died from complications of severe malaria (mortality rate: 6.9%).
As for safety, the most common adverse reactions observed in trials included acute renal failure requiring dialysis, hemoglobinuria, and jaundice. In addition, cases of post-treatment hemolytic anemia severe enough to require transfusion have been reported.
“We are extremely pleased to have secured this important regulatory milestone for Artesunate for Injection,” said Bryan Smith, MD, Chief Medical Officer at Amivas. “As most medical professionals know, when a patient with severe malaria arrives in the clinic, emergency room or elsewhere, immediate treatment with a safe, efficacious, fast-acting, injectable therapy is absolutely critical to saving that life.”
Artesunate for Injection will be supplied in single-dose vials containing 110mg of artesunate as a powder for reconstitution with the supplied sterile diluent. Until commercial availability, healthcare professionals can obtain investigational IV artesunate by contacting the CDC.
For more information visit amivas.com.
