Entasis launches expanded access program for A. baumannii drug
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Entasis Therapeutics recently announced the availability of an expanded access program for sulbactam-durlobactam, an investigational treatment for Acinetobacter baumannii infections, including carbapenem- and multidrug-resistant strains.
Physicians can request preapproval access to sulbactam-durlobactam (SUL-DUR), which is administered intravenously every 6 hours, for patients with a documented carbapenem-resistant A. baumannii infection who have no alternative treatment options and are not able to participate in Entasis Therapeutics’ phase 3 ATTACK trial, David Altarac, MD, chief medical officer of Entasis Therapeutics, told Healio Primary Care.
“We strive to respond to requests as quickly as possible,” he said. “Once we receive a request, we meet internally to discuss, then immediately have a meeting with the patient’s treatment team to assess the situation and come to a quick decision. Our experience has been that within 1 to 2 hours of the request, a decision has been made.”
If access is approved, which requires authorization from the FDA, the drug is transferred to the patient “as quickly as possible,” Altarac said.
“In these critical situations, every moment counts,” he added. “Our experience has been that the drug is on site within 48 hours of the initial request.”
In 2017, WHO placed carbapenem-resistant A. baumannii on its list of priority pathogens with a “critical need” for research and development. That same year, the CDC estimated there were about 8,500 carbapenem-resistant Acinetobacter infections among hospitalized patients and 700 deaths in the United States.
Physicians who are seeking preapproval access to SUL-DUR can submit requests to Expandedaccess@entasistx.com, according to a company press release. The expanded access program is currently only available for patients in the United States.
References:
CDC. Acinetobacter in healthcare settings. https://www.cdc.gov/hai/organisms/acinetobacter.html. Accessed February 2, 2021.
Global Newswire. Entasis Therapeutics announces sulbactam-durlobactam expanded access program for patients in the U.S. https://www.globenewswire.com/news-release/2021/01/26/2164231/0/en/Entasis-Therapeutics-Announces-Sulbactam-Durlobactam-Expanded-Access-Program-for-Patients-in-the-U-S.html. Accessed February 2, 2021.
Perspective
Back to TopKrutika Kuppalli, MD
I think this is an important development since we are increasingly seeing more multidrug-resistant organisms, which include carbapenem-resistant A. baumanii. Having more therapeutics to treat these infections is important and I am glad to see pharmaceutical companies investing in the research and development of these anti-infective agents for these life-threatening conditions. I think it is important for primary care and internal medicine providers to know about these medications so when they have patients with these infections, they can refer them to the appropriate infectious disease physicians so they can potentially receive this therapy, if deemed appropriate.
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