Ebola: US Regulatory Agency Approves New Drug for Human Treatment
The United State Food and Drug Administration have approved TKM-Ebola, a drug developed by Tekmira Pharmaceuticals Corporatin to be used in Humans.
The U.S. regulators had previously put tests of the drug on hold.
The Vancouver-based company said yesterday that the agency altered the therapy’s status to possibly allow its use in those infected with the virus that has killed over 932 people in West Africa since March.
“We have been closely watching the Ebola virus outbreak and its consequences, and we are willing to assist with any responsible use of TKM-Ebola,” Tekmira’s Chief Executive Officer Mark Murray said in a statement.
“The foresight shown by the FDA removes one potential roadblock to doing so.” Stephanie Yao, an FDA spokeswoman, said she couldn’t discuss specific products and deferred questions to Tekmira.
The company didn’t say in the statement if or when it would begin tests, only that it might, and didn’t say how much of the drug is available. Julie Rezler, a Tekmira spokeswoman, didn’t return calls for comment after the statement was released.
The World Health Organization is planning to convene a panel of medical ethicists next week to explore the use of experimental drugs for Ebola.
The U.S. also is developing policy about how such medicines should be distributed in future outbreaks, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. Tekmira’s drug wasn’t the treatment administered to two American aid workers infected with Ebola in Liberia.
The aid workers, Kent Brantly and Nancy Writebol, each received a dose of Mapp Biopharmaceutical Inc.’s experimental therapy, called ZMapp, in Liberia before being flown to the U.S. They are being treated at Emory University Hospital in Atlanta and have shown signs of improvement.
Nigeria’s health ministry said it had written to the director of the U.S. Centers for Disease Control and Prevention requesting access to Mapp’s drug.
Human testing of Tekmira’s Ebola treatment was put on hold last month due to safety concerns. Tekmira said the studies were suspended because of an inflammatory, flu-like response in healthy volunteers taking higher doses of the drug. The company previously said it expected the hold to be resolved by the end of the year.
The drug stops the action of specific Ebola virus genes, which keeps the virus from making more of itself, said Thomas Geisbert, a virologist at University of Texas Medical Branch at Galveston.
In a 2010 study, researchers tested the drug on four monkeys, giving them seven doses of the medicine after they were infected with high doses of Ebola. The drug worked to protect them from the disease. It is one of only three treatments that have been shown to completely protect monkeys against Ebola, Geisbert said in an e-mail.
Yao, the FDA spokeswoman, said earlier this week that while the agency couldn’t comment on the development of a specific product like TKM-Ebola, it individually considers each human study based on the risks and benefits involved.
“A future proposal for a study or emergency use in a different population, for example in patients with disease, might have an acceptable risk-benefit balance,” she said.
“If the benefits of studying the product on an individual outweigh the risks, we may consider permitting that study to proceed.”
TKM-Ebola had earlier been fast-tracked by regulators in a process designed to expedite the review of drugs for serious conditions and unmet medical needs. The therapy is in the first of three stages of clinical trials usually required by regulators for approval.
Besides Mapp’s antibody therapy and Tekmira’s treatment, the U.S. National Institute of Health is developing a vaccine, which may begin enrollment in a Phase 1 clinical trial by this fall.
Other companies developing drugs for the deadly disease include Fujifilm Holdings Corp., BioCryst Pharmaceuticals Inc., and Sarepta Therapeutics Inc.
The Ebola virus has sickened 1,711 people in West Africa in the latest outbreak, according to the World Health Organization. It has no cure. The current treatment is to hydrate patients, replace lost blood and use antibiotics to fight off opportunistic infections. The hope is that the patient’s immune system will be able to ward off the disease.
Ebola has historically killed as many as 90 percent of those who contract it. The current outbreak has claimed the lives of about 60 percent of its victims.
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