Amivas’ Artesunate Gets FDA Approval As Only Drug In US To Treat Severe Malaria
The U.S. Food and Drug Administration (FDA) granted approval for Artesunate for Injection 110 mg, powder and solvent for solution to biopharmaceutical company Amivas (US), LLC as the only FDA-approved drug now in the U.S. for the first-line treatment of severe malaria in adult and pediatric patients.
Intravenous (IV) Artesunate is also the first FDA-approved product that Amivas has introduced to their commercial portfolio.
There has been no FDA-approved drug to treat severe malaria in the U.S. since the marketing of IV quinidine was discontinued by the manufacturer in March 2019.
IV artesunate is the recommended World Health Organization (WHO) first-line treatment for severe malaria. It is in a group of drugs known as “artemisinin derivatives” and is on the WHO Model List of Essential Medicines.
However, it was neither FDA-approved nor commercially available in the U.S. Until now, 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 the drug available under the CDC-sponsored expanded access IND 76,725, in effect per FDA’s authorization since 2007until nationwide availability of Amivas-produced Artesunate for Injection is in place in the next few months.
The development of Artesunate for Injection in the US has been under US Army Medical Research and Development Command (USAMRDC).
The FDA approval will allow Amivas to now manufacture, distribute, and commercialize Artesunate for Injection and is completing set-up of a nationwide product distribution network.
Malaria is a parasitic disease transmitted by a mosquito bite. People with malaria often experience fever, chills and flu-like illness, and without appropriate treatment, they may develop severe complications, such as kidney failure, seizures, mental confusion, coma and death.
According to the Centers for Disease Control and Prevention (CDC), an estimated 2,000 cases of malaria are diagnosed in the United States each year, with 300 of those infected having severe disease.
IV artesunate was approved by the FDA after its safety and efficacy for the treatment of severe malaria was primarily evaluated in a randomized controlled trial in Asia (Trial 1) and a supportive published randomized controlled trial in Africa (Trial 2).
Trial 1 enrolled 1,461 patients who received either IV artesunate or the comparator drug quinidine and included 202 pediatric patients younger than 15 years. Trial 2 included 5,425 randomized pediatric patients younger than 15 years of age with severe malaria who were treated with artesunate or quinidine.
In both trials, the number of patients treated with IV artesunate who died in the hospital was significantly lower than the number who died in the control group treated with quinidine.
The FDA granted this application Priority Review designation and Orphan Drug designation, which provides expedited time frame as well as incentives to assist and encourage the development of drugs for rare diseases.
Source: Read Full Article