Infectious Disease

Entasis launches expanded entry program for A. baumannii drug

February 02, 2021

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Entasis Therapeutics recently announced the availability of an expanded access program for Sulbactam-Durlobactam, a test treatment for Acinetobacter baumannii infections, including carbapenem and multi-drug resistant strains.

Physicians may request pre-approved access to sulbactam durlobactam (SUL-DUR) administered intravenously every 6 hours for patients with documented carbapenem-resistant A. baumannii infection who have no alternative treatment options and cannot participate in Entasis Therapeutics will be phase 3 ATTACK study, David Altarac, MD, Chief Medical Officer of Entasis Therapeutics, said Healio Primary Care.

“We try to answer queries as quickly as possible,” he said. “As soon as we receive an inquiry, we meet internally to discuss and then immediately meet with the patient’s care team to assess the situation and make a quick decision. In our experience, a decision was made within 1 to 2 hours of the request. ”

If access is approved, which requires FDA approval, the drug will be delivered to the patient “as soon as possible,” Altarac said.

“In these critical situations, every moment counts,” he added. “Our experience has shown that the drug is on site within 48 hours of the first request.”

In 2017, the 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 that there were approximately 8,500 carbapenem-resistant Acinetobacter infections in hospital patients and 700 deaths in the United States.

Physicians seeking pre-approved access to SUL-DUR can send inquiries to Expandedaccess@entasistx.com, according to a company press release. The extended access program is currently only available to patients in the United States.

References:

CDC. Acinetobacter in Health Care. https://www.cdc.gov/hai/organisms/acinetobacter.html. Accessed February 2, 2021.

Global Newswire. Entasis Therapeutics Announces Expanded Sulbactam-Durlobactam Access Program for Patients in the United States. Extended Access Program for Patients in the USA.html. Accessed February 2, 2021.

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Krutika Kuppalli, MD

I think this is an important development as we are increasingly seeing multidrug-resistant organisms, which includes carbapenem-resistant A. baumanii. It is important to have more therapeutics to treat these infections, and I am excited to see drug companies investing in the research and development of these anti-infectives for these life-threatening diseases. I think it is important that primary care and internal medicine providers are aware of these drugs. If they have patients with these infections, they can refer them to the appropriate infectious disease doctors so they may receive this therapy when it is deemed appropriate.

Krutika Kuppalli, MD

Peer Perspective Board Member, Healio Primary Care Assistant Professor of Medicine, Vice Chairman of the Medical University of South Carolina, Global Health Committee of the Society of America Global Health Committee, Emerging Head of Biosafety, Johns Hopkins Center for Health Security

Disclosure: Kuppalli reports that he is a member of the advisory board of GlaxoSmithKline.

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