The Food and Drug Administration (FDA) on Monday approved the use of an experimental drug that has been hailed as one of the pharmaceutical industry’s best chances at fighting the Ebola virus.
Chimerix, a North Carolina-based biopharmaceutical company, announced Monday that it has received approval to administer an antiviral drug called brincidofovir that has successfully treated Ebola in lab tests.
The drug has also been tested by the Centers for Disease Control and Prevention and the National Institutes of Health, though it is not expected to win approval for wide public use until late 2016.
“We are hopeful that brincidofovir may offer a potential treatment for Ebola Virus Disease during this outbreak,” the company’s president and CEO, M. Michelle Berrey, said in a release.
Another drug that has been used to treat Ebola-infected patients, TKM-Ebola, has also been permitted for emergency use by the FDA.
TKM-Ebola was used on American doctor Kent Brantly, who recovered from the disease after he was treated in an Atlanta hospital last month. The drug, produced by Canadian drugmaker Tekmira, was given a “fast track” designation and is still undergoing clinical trials.
The FDA has been under pressure to speed up its drug approval process, which typically takes years. Agency officials have said that the current pace of reviewing new drug applications to fight Ebola — taking just days instead of months or years — set agency records.
Ebola has killed at least 3,439 people across West Africa. One U.S. hospital is also treating an Ebola-infected patient, who is in critical condition as he battles the deadly virus. Local news outlets reported Monday that the patient is not being treated with experimental drugs that were used to treat several other Americans who had contracted, and later survived, the disease.
Some lawmakers have been cautious about speeding up the U.S. clinical response to Ebola.
At a hearing held by a House Foreign Relations subcommittee last month, Rep. Betty McCollum (D-Minn.) warned against turning Africa into “a testing ground” with drugs that haven’t been properly vetted.
“I know there’s a lot of pressure, but I, for one, think we need to follow the science,” McCollum said. She added that an untested vaccine could “discredit” U.S. efforts to combat the disease and make people more fearful across the affected areas.
http://thehill.com/policy/healthcare/219856-fda-approves-use-of-experimental-ebola-drug