Tekmira Pharmaceuticals Corporation says FDA will allow expanded use of TKM-Ebola
Patients can be treated with experimental drug if all other treatment options exhausted
TKM-Ebola has already been given to a number of patients
An experimental Ebola drug that’s still in development may now be used to treat more people with the disease, according to Tekmira Pharmaceuticals Corporation.
The drug company said the U.S. Food and Drug Administration has authorized expanded use of TKM-Ebola under its Investigational New Drug application rule.
Expanded access allows patients outside of a clinical trial to be treated with an investigational drug if they have a life-threatening disease and have exhausted any other approved treatment options. The FDA allows this kind of access on a case-by-case basis.
“We have worked with the FDA and Health Canada to establish this framework and a treatment protocol allowing us to do what we can to help these patients,” Dr. Mark J. Murray, Tekmira’s president and CEO, said in a statement.
In January, a small human trial of TKM-Ebola was put on hold after one volunteer developed moderate gastrointestinal side effects after receiving a high dose of the medication.
Then last month, the FDA modified the hold to a “partial clinical hold.” This meant that Tekmira could give the drug to doctors or hospitals that requested it on an emergency basis.
According to Murray, the treatment has already been given to a number of patients and “repeat infusions” of the drug have been well tolerated. Though more Ebola patients may now be given the drug, he warns that they will not be enrolled in a controlled clinical trial.
FDA spokesperson Stephanie Yao said federal law and FDA regulations prevent the agency from disclosing information about products under development because it’s considered confidential.
“While the FDA cannot comment on the development of specific medical products,” Yao said, “it’s important to note that every FDA regulatory decision is based on a risk-benefit assessment of scientific data that includes the context of use for the product and the patient population being studied.”
According to the company, the FDA granted Tekmira fast track status to develop TKM-Ebola back in March. Murray said their supply is limited, “but we will continue to help where we can.”
CNN’s Caleb Hellerman contributed to this story.