By NewsDesk  @infectiousdiseasenews

Frederick, Maryland company specializing in treatments for rare and neglected tropical diseases, Amivas, announced Tuesday that Artesunate for Injection 110 mg, powder and solvent for solution has received marketing approval by the US Food and Drug Administration (FDA). Artesunate for Injection is indicated for the initial treatment of severe malaria in adult and pediatric patients.

P. falciparum rings and gametocyte/CDC

Amivas will now manufacture, distribute, and commercialize Artesunate for Injection and is completing set-up of a nationwide product distribution network. Prior to FDA approval, access to investigational IV Artesunate had been managed by the Centers for Disease Control and Prevention (CDC) since 2007 via an expanded access investigational new drug (IND) program.

According to the CDC, approximately 2,000 cases of malaria are diagnosed in the United States each year, with 300 of those infected having severe disease.  Severe malaria should be treated with intravenous (IV) antimalarial medications. The only U.S. Food and Drug Administration- (FDA-) approved IV antimalarial in the United States, IV quinidine, has been discontinued. As a result, CDC is providing IV artesunate for the treatment of all severe malaria cases. With the discontinuation of IV quinidine, IV artesunate is now the first-line drug for treatment of severe malaria in the United States.

“This approval will now give patients more access to a lifesaving drug,” said John Farley, M.D., acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “Furthermore, the risk of developing severe malaria emphasizes the importance of taking medications to prevent malaria and using mosquito avoidance measures when traveling to malaria-endemic areas.”

“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. Given today’s FDA approval of Artesunate for Injection and the deep expertise that Amivas can bring to the challenges of treating rare tropical diseases, we look forward to making significant ongoing contributions to saving the lives of patients with severe malaria.”

Malaria is one of the world’s leading killers of people, especially children. Severe malaria, a medical emergency, typically includes neurologic symptoms, severe anemia, acute renal injury,
acute respiratory distress syndrome, or jaundice, as a large number of the patient’s red blood cells become infected by a malaria parasite. Uncomplicated falciparum malaria can progress
rapidly to severe forms of the disease, especially in people with no or low immunity, and severe falciparum malaria is almost always fatal without treatment. Prompt, effective treatment within
24-48 hours of the onset of malaria symptoms is necessary.

Malaria is a rare disease in the US. Therefore, it is not always recognized, diagnosed and treated in timely fashion. Nearly all cases in the US occur in persons who acquire the infection
while in a malaria endemic area and who are diagnosed after returning to the US. Most are US residents with no acquired immunity to malaria and who are, therefore, at risk of developing
severe malaria. A major contributing factor to continued malaria-associated mortality in the US is delay in initiation of appropriate treatment. Malaria chemoprophylaxis and the use of bed nets and insect repellents help reduce the risk of contracting malaria.