viernes, 30 de marzo de 2018

FDA approves Leukine for Acute Radiation Syndrome | Blood supply model could help nation prepare for emergencies

U.S. Food and Drug Administration - Medical Countermeasures Initiative Update
Radiological and nuclear emergency preparedness information from FDA Image: vials (Shutterstock)

FDA approves Leukine for Acute Radiation Syndrome

Adds to the country's available treatments in the event of radiological or nuclear emergency

On March 29, 2018, the FDA approved use of Leukine (sargramostim) to increase survival in adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS).

Myelosuppression occurs when radiation damages the bone marrow. Suppression of the bone marrow blocks the production of blood cells. Leukine can help patients with H-ARS by facilitating recovery of bone marrow cells that develop into white blood cells that help fight off infections.

Leukine was shown to increase survival when administered up to 48 hours after total body irradiation exposure at doses expected to be fatal to 50% of those exposed subjects under conditions of minimal supportive care.

Leukine is the third FDA-approved medical countermeasure (MCM) that is indicated to increase survival in patients exposed to myelosuppressive doses of radiation. It was approved by FDA based on efficacy studies in animals (under the Animal Rule), as efficacy studies in humans could not be ethically conducted. Leukine was originally approved in 1991 and was originally indicated to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML), and subsequently approved for several oncology-related indications.

The most commonly reported side effects associated with Leukine injections are fever, injection site reactions, and shortness of breath.

Other products from a similar pharmacological class and approved for the same indication are:

FDA Blood Supply and Demand Simulation Model Could Help Nation Prepare for Emergencies 
FDA has developed a model that estimates the amount of blood available in the U.S. during both routine conditions and emergencies. It can be valuable for emergency preparedness planning and for responses requiring blood transfusions.
The amount of blood that is collected and used in different regions of the country varies. The FDA model of the U.S. blood supply enables public 
health officials to estimate the availability of blood in each region at any given time. This helps minimize disruption and avoid shortages in the blood supply.

Image: The amount of blood that is collected and used in different regions of the country varies. The FDA model of the U.S. blood supply enables public health officials to estimate the availability of blood in each region at any given time. This helps minimize disruption and avoid shortages in the blood supply. 

EUA updates
Emergency Use Authorization
EUA reissuance
  • March 27, 2018: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay - In response to CDC's request, FDA reissued the April 22, 2013, EUA in its entirety with the CDC-requested amendments incorporated. This test is for the presumptive detection of novel influenza A (H7N9) virus in conjunction with the FDA-cleared CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel in real-time RT-PCR (rRT-PCR) assays in patients with signs and symptoms of respiratory infection. Additional technical information, including updated fact sheets and instructions for use

Reminder:
Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer.

Information about Zika EUAs and amendments is available on the FDA Zika virus response updates page. Also see the latest CDC Zika Laboratory Guidance, last updated July 24, 2017.

Events

Information for industry
More: MCM-Related Guidance by Date



In case you missed it
Drugs@FDA mobile app screenshot
  • From HHS ASPR - Fighting microscopic threats through international collaboration: Health ministers use lessons learned from the 1918 influenza pandemic to strengthen pandemic preparedness and global health security - One hundred years ago, the 1918 influenza pandemic caused massive devastation, ultimately infecting over 500 million people and killing between 50 and 100 million individuals worldwide. During recent outbreaks of influenza, Ebola, and other emerging infectious diseases, we have learned how critical collaboration among countries and international organizations is for an expedited and more effective response. Working together with our partners to strengthen global health security is crucial to protect Americans from pandemics and other health security threats despite whether they start at home or abroad. (March 19, 2018)
  • From NIH - H7N9 Influenza Vaccine Clinical Trials Begin - H7N9 is an avian influenza virus with pandemic potential. To date, only a few infections in humans have been found, all outside of the United States. However, should the virus change to transmit more easily between people, it could cause widespread suffering: H7N9 has a high mortality rate for a flu virus. To prepare for this possibility, NIAID is sponsoring two new Phase 2 trials of an H7N9 inactivated influenza vaccine, which may provide protection against the virus. The trials, conducted through the Vaccine and Treatment Evaluation Unit(VTEU) network, will test the vaccines at various doses, with and without adjuvant, and in conjunction with the seasonal influenza vaccine. (March 15, 2018)
  • From CDC - National Outbreak Reporting System (NORS) - A new online tool from CDC lets you search data on outbreaks of intestinal illness spread through food, water, animal contact, person-to-person contact, and more. (March 15, 2018)

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