Tweet
Source: http://www.cidrap.umn.edu/news-persp...an-jul-13-2018
News Scan for Jul 13, 2018
First smallpox drug approved; Suspected Ebola cases
Filed Under:
Ebola; VHF; Smallpox; Bioterrorism
FDA approves SIGA's TPOXX as first drug for treating smallpox
The US Food and Drug Administration (FDA) today approved TPOXX (tecovirimat), made by SIGA Technologies, as the first drug with an indication for treating smallpox, a disease that has been eradicated but could still be used as a bioweapon.
TPOXX's effectiveness against smallpox was established with studies that measured survival in animals infected with viruses closely related to the variola virus, which causes smallpox. The FDA approved TPOXX under its Animal Rule, which allows efficacy findings from well-controlled animal studies to support an FDA approval when it is not feasible or ethical to conduct efficacy trials in people.
TPOXX's safety was evaluated in 359 healthy human volunteers who did not have a smallpox infection. The most frequently reported side effects were headache, nausea, and abdominal pain.
"To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons," said FDA Commissioner Scott Gottlieb, MD. "This new treatment affords us an additional option should smallpox ever be used as a bioweapon.
"This is the first product to be awarded a Material Threat Medical Countermeasure priority review voucher. Today's action reflects the FDA's commitment to ensuring that the U.S. is prepared for any public health emergency with timely, safe, and effective medical products."
TPOXX also received Orphan Drug designation, which provides incentives for drugs for rare diseases. The Material Threat Medical Countermeasure priority review voucher provides additional incentives for medical products against specific chemical, biological, radiological, and nuclear threats.
TPOXX was developed in conjunction with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA). SIGA is based in New York City.
Jul 13 FDA press release
More suspected Ebola cases reported in the DRC
According to the latest situation report published yesterday by the World Health Organization (WHO), the Democratic Republic of the Congo (DRC) reported 11 more suspected Ebola cases in an outbreak that's been ongoing since April but is winding down.
Lab testing has cleared 6 of the 11 cases, but the status of the remaining 5 is still unknown. No new cases have been confirmed since early June, with the last Ebola patient diagnosed on Jun 2, the WHO said.
Since the beginning of the outbreak on Apr 4, 38 cases of Ebola have been confirmed and 15 cases have been labeled probable (deaths for which it was not possible to collect laboratory specimens for testing). Of these 53 patients, 29 died, resulting in a case-fatality rate of 54.7%.
The outbreak will be declared over when 42 days (two transmission cycles) following the last possible exposure to a confirmed case have passed.
"In the absence of ongoing transmission, the probability of exported cases is low and diminishing, and has been further mitigated by the undertaking of preparedness activities and establishment of contingency plans in neighbouring countries," the WHO said. "WHO has assessed the public health risk to be low at the regional and global levels."
Jul 12 WHO situation report
News Scan for Jul 13, 2018
First smallpox drug approved; Suspected Ebola cases
Filed Under:
Ebola; VHF; Smallpox; Bioterrorism
FDA approves SIGA's TPOXX as first drug for treating smallpox
The US Food and Drug Administration (FDA) today approved TPOXX (tecovirimat), made by SIGA Technologies, as the first drug with an indication for treating smallpox, a disease that has been eradicated but could still be used as a bioweapon.
TPOXX's effectiveness against smallpox was established with studies that measured survival in animals infected with viruses closely related to the variola virus, which causes smallpox. The FDA approved TPOXX under its Animal Rule, which allows efficacy findings from well-controlled animal studies to support an FDA approval when it is not feasible or ethical to conduct efficacy trials in people.
TPOXX's safety was evaluated in 359 healthy human volunteers who did not have a smallpox infection. The most frequently reported side effects were headache, nausea, and abdominal pain.
"To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons," said FDA Commissioner Scott Gottlieb, MD. "This new treatment affords us an additional option should smallpox ever be used as a bioweapon.
"This is the first product to be awarded a Material Threat Medical Countermeasure priority review voucher. Today's action reflects the FDA's commitment to ensuring that the U.S. is prepared for any public health emergency with timely, safe, and effective medical products."
TPOXX also received Orphan Drug designation, which provides incentives for drugs for rare diseases. The Material Threat Medical Countermeasure priority review voucher provides additional incentives for medical products against specific chemical, biological, radiological, and nuclear threats.
TPOXX was developed in conjunction with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA). SIGA is based in New York City.
Jul 13 FDA press release
More suspected Ebola cases reported in the DRC
According to the latest situation report published yesterday by the World Health Organization (WHO), the Democratic Republic of the Congo (DRC) reported 11 more suspected Ebola cases in an outbreak that's been ongoing since April but is winding down.
Lab testing has cleared 6 of the 11 cases, but the status of the remaining 5 is still unknown. No new cases have been confirmed since early June, with the last Ebola patient diagnosed on Jun 2, the WHO said.
Since the beginning of the outbreak on Apr 4, 38 cases of Ebola have been confirmed and 15 cases have been labeled probable (deaths for which it was not possible to collect laboratory specimens for testing). Of these 53 patients, 29 died, resulting in a case-fatality rate of 54.7%.
The outbreak will be declared over when 42 days (two transmission cycles) following the last possible exposure to a confirmed case have passed.
"In the absence of ongoing transmission, the probability of exported cases is low and diminishing, and has been further mitigated by the undertaking of preparedness activities and establishment of contingency plans in neighbouring countries," the WHO said. "WHO has assessed the public health risk to be low at the regional and global levels."
Jul 12 WHO situation report