SILVER SPRING, Md.,
May 26, 2020 /PRNewswire/ -- Today,
the U.S. Food and Drug Administration approved artesunate for
injection to treat severe malaria in adult and pediatric patients.
Treatment of severe malaria with intravenous (IV) artesunate should
always be followed by a complete treatment course of an appropriate
oral antimalarial regimen.
Prior to this approval, IV artesunate was only available to
patients through the FDA's Expanded Access program, which allowed
the U.S. Centers for Disease Control and Prevention (CDC) to
provide IV artesunate to U.S. patients with severe malaria and to
patients with uncomplicated malaria who are unable to take oral
medications under an investigational new drug (IND) protocol. There
has been no FDA-approved drug for treatment of severe malaria in
the United States since the
marketing of quinidine was discontinued by the manufacturer in
March 2019.
"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."
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. Most
people diagnosed with malaria in the
United States acquire it during travel to countries with
malaria. 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.
The safety and efficacy of IV artesunate 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 quinine 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 quinine. In both
trials, the number of patients treated with artesunate who died in
the hospital was significantly lower than the number who died in
the control group treated with quinine.
In Trial 1, the most common adverse reactions in patients with
malaria treated with IV artesunate were acute renal failure
requiring dialysis, hemoglobinuria and jaundice. The safety profile
in Trial 2 was generally similar to Trial 1.
Artesunate should not be used in patients with known serious
allergy to artesunate such as anaphylaxis.
The FDA granted this application Priority Review designation,
under which the FDA's goal is to take action on an application
within an expedited time frame and Orphan Drug designation,
which provides incentives to assist and encourage the development
of drugs for rare diseases. The FDA granted approval of artesunate
for injection to Amivas.
Additional Resources:
- CDC – Intravenous Artesunate for Treatment of Severe
Malaria
- FDA – Expanded Access
Media Contact: Alison
Hunt, 240-402-0764
Consumer Inquiries: Email or 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for
regulating tobacco products.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/fda-approves-only-drug-in-us-to-treat-severe-malaria-301065693.html
SOURCE U.S. Food and Drug Administration