FDA Eases Restrictions on Experimental Drug For Use on Ebola Patients
The US Food and Drug Administration has loosened restrictions on the experimental medicines of Ebola and allowed Tekmira Pharmaceuticals' TKM-Ebola drug to be used on Ebola patients.
The FDA has moved the drug from a "full hold" to a "partial hold," which means Tekmira can use the drug in limited experiments.
"We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients. 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. The foresight shown by the FDA removes one potential roadblock to doing so," said Dr Mark Murray, CEO and president of Tekmira, reports CNN Money.
"This current outbreak underscores the critical need for effective therapeutic agents to treat the Ebola virus. We recognize the heightened urgency of this situation, and are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols."
Tekmira, in collaboration with Boston University and the United States Army Medical Research Institute for Infectious Diseases, has already conducted tests on the drug's efficacy over non-human primates with Ebola infection in 2010.
This January the FDA gave approval for Phase1 trials which was moved to fast track designation in March around the same time as the Ebola virus spread picked up in West Africa, according to RT.com.
A little know pharmaceutical firm , Mapp Biopharmaceutical Inc., San Diego , has developed another drug, called Zmapp, against Ebola, which was given to the two American aid workers who contacted the disease in Liberia. The drug was in the experimental stage and had not been tested on humans, according to a company statement.
It boosts the immune system and consists of antibodies from lab animals exposed to the virus.
According to the latest World Health Organization figures published Wednesday, there are over 1,700 suspected and confirmed cases of Ebola in the four West African countries, and 932 have died from the disease.
