PDSA e-News: January 31, 2018


‘Compassionate Use’ Treatment Available for ITP Patients Unresponsive to Past Therapies

medical chartRigel Pharmaceuticals’ ITP drug candidate fostamatinib is now available through an Expanded Access/ Compassionate Use Program for certain patients. Fostamatinib works by protecting platelets from antibody-mediated destruction and has a mechanism of action different from currently approved therapies for ITP. Expanded Access, sometimes also referred to as “Compassionate Use”, is allowed by the FDA for therapies still under clinical trial review to patients for which there are no comparable alternatives for treatment. Through such programs, patients may be able to access investigational new drugs outside of the clinical trial context. Unlike the clinical trial setting, the primary purpose of compassionate use is to use the investigational drug for patient treatment purposes, rather than to gather controlled data on safety and effectiveness. Physicians can request compassionate use of Fostamatinib for chronic ITP if their patient is not eligible to enroll in Rigel’s clinical trial and no alternative treatment exists, via completion of an application at http://eap.rigel.com. The program is available only to US physicians at this time.

NIH Clinical Trials: https://clinicaltrials.gov/ct2/show/NCT03363334.

Rigel Pharmaceuticals, Inc. “Expanded Public Expanded Access Policy.” Rigel Pharmaceuticals, Inc. December 2017. http://bit.ly/2DiF5Vm.


Frequent TV Watching Associated with Increased Blood Clots

watching tvNew findings released from the American Heart Association’s Scientific Sessions uncovered that people who report watching television often have a doubled risk for blood clots and heart disease compared to those who infrequently spend time “plugged-in,” even with exercise. Blood clots, or venous thromboembolisms, affect up to 600,000 Americans per year and are one of the most commonly diagnosed vascular conditions. Some people with ITP are more prone to blood clots; those who have been splenectomized have a five-fold increase of clotting. Researchers attributed the correlation between clots and TV-watching to prolonged sitting, which has also been found to increase the risk of diabetes, heart disease, and other chronic health issues.

Paddock, Catherine, PhD. “More TV Viewing Linked to Higher Risk of Blood Clots in Veins.” Medical News Today. November 2017. http://bit.ly/2AHY3Pl.






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