Amivas Announces FDA Approval of Artesunate for Injection for Severe Malaria

Amivas announced 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. It is the first FDA-approved product that Amivas, headquartered in Frederick, Maryland, has introduced to their commercial portfolio.

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. The CDC will continue to make investigational IV Artesunate available under the CDC-sponsored expanded access IND 76,725, in effect per FDA's authorization since 2007 until nationwide availability of Amivas-produced Artesunate for Injection is in place in the next few months.

"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."

Until Amivas' Artesunate for Injection is available in hospitals, healthcare professionals seeking IV artesunate for treatment of patients with severe malaria should contact the CDC for obtaining investigational IV Artesunate.

Development of Artesunate for Injection in the US has been under US Army Medical Research and Development Command (USAMRDC). Within USAMRDC, the Walter Reed Army Institute of Research and the US Army Medical Materiel Development Activity (USAMMDA) joint collaborative work has provided the CDC a constant supply of IV artesunate since 2007. USAMMDA established a cooperative research and development agreement with Amivas to modernize Artesunate manufacture and register the product with the FDA.

"FDA approval of Artesunate for Injection is another notable achievement for the US Army in its long history of developing therapies for combating malaria. With a lack of alternate FDA approved therapies to treat life-threatening severe malaria, Artesunate for Injection fills a critical gap for the military and US population. This difficult undertaking was accomplished through a competitively bid, public/private partnership and is testament to the professionalism and dedication of the team involved," said Major Victor Zottig, PhD, Artesunate Product Manager for USAMMDA.