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Around the nation: FDA approves first treatment to slow type 1 diabetes progression


FDA recently approved Sanofi's Tzield to slow the progression of type 1 diabetes in children ages eight to 17, in today's bite-sized hospital and health industry news from Georgia and Maryland. 

  • Georgia: CDC has raised its Ebola response to the highest level as the outbreak continues to spread rapidly across Congo and Uganda. Since May, more than 1,100 people in Congo and Uganda have tested positive for the virus, and at least 250 people have died. Currently, CDC has around 100 staff members deployed domestically and internationally for the Ebola response. "Elevating the response level reflects the urgency, scale, and complexity of the outbreak, and allows CDC to bring additional resources to support the coordination and operational needs of our response," said Satish Pillai, CDC's Ebola response incidence manager. "We are very concerned about the trajectory of cases, which are rising rapidly, as well as the continued geographic spread." However, Pillai noted that there is currently no risk of Ebola in the United States. The Trump administration has asked Congress for an additional $1.4 billion to fund the Ebola response. CDC also recently issued travel restrictions through July 21 for non-U.S. citizens who were recently in Congo, South Sudan, or Uganda to prevent potential spread of the virus. (Weixel, The Hill, 6/26)
  • Maryland: NIH created the Office of Research Innovation, Validation, and Application (ORIVA), which is aimed at reducing animal-based research testing. According to NIH, ORIVA will focus on increasing the use of testing methods that "better reflect human biology" instead of animal testing. Alternative testing methods include 3D human tissue models and computational tools. "Complex computational models, 3D human tissue models, and other emerging technologies have improved by leaps and bounds in recent years and may hold the key to a more effective research enterprise,” said NIH Director Jay Bhattacharya. "By strategically capitalizing on these tools and encouraging further innovation, NIH aims to steer biomedical research in this direction." Other federal agencies have also made efforts to reduce animal testing, which is a goal of HHS Secretary Robert F. Kennedy Jr. Last April, FDA launched an initiative to reduce animal testing in preclinical safety trials, and the Environmental Protection Agency recently announced plans to expand alternatives to animal studies. (Choi, The Hill, 6/16)
  • Maryland: FDA recently granted accelerated approval to Sanofi's new drug Tzield to delay the decline of endogenous insulin production in children ages eight to 17 years diagnosed with stage 3 type 1 diabetes. Tzield is the first treatment approved to modify the progression of type 1 diabetes. The approval was based on the Phase III PROTECT study, which included 328 children and adolescents recently diagnosed with stage 3 type 1 diabetes. The patients were randomly assigned to receive either Tzield or a placebo. In the study, patients who received Tzield had a slower decline in insulin production than those who received a placebo. "We welcome this accelerated approval by the FDA, which recognizes the potential of Tzield to delay the progression of recently diagnosed stage 3 type 1 diabetes in children aged 8 to 17 years," said Sanofi's Christopher Corsico. "Tzield will now offer a new pathway in the treatment paradigm of stage 3 type 1 diabetes, one that we hope will further enable health care providers in the U.S. to take a more proactive approach to disrupt the underlying autoimmune attack against insulin-producing beta cells." (Jeffries, Becker's Hospital Review, 6/15; Solomon, Medical Xpress, 7/2)

Q&A with a clinical pharmacist: Reimagining diabetes care

What would it take to make outpatient diabetes care as coordinated as inpatient care? A clinical pharmacist shares a practical vision for getting there.


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