FDA approves MSD’s combo therapy Recarbrio for urinary tract and intra-abdominal infections
MSD has announced the approval from the FDA of its combination therapy Recarbrio (imipenem, cilastatin and relebactam) in the treatment of adult patients with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
The therapy combines the penem antibacterial drug imipenem, the renal dehydropeptidase inhibitor cilastatin sodium, and the beta lactamase inhibitor relebactam. Imipenem plus cilastatin previously secured approval with the FDA under the brand name Primaxin, and MSD confirmed that data submitted in support of that application were also used to prove the safety and efficacy of this new submission; the introduction of relebactam to the combination was assessed through data gathered in in vitro trials and in animal models of infection.
The FDA warned of a risk of using Recarbrio in patients also using ganciclovir, divalproex sodium unless it is deemed beneficial due to an increased threat of seizures.
“Recarbrio provides an important addition to our toolkit in the ongoing fight against infections caused by certain Gram-negative pathogens,” commented Dr Keith Kaye, Professor of Medicine and Director of Research for the Division of Infectious Diseases at the University of Michigan Heath System, and a principal investigator in the clinical study programme into the drug. “Recarbrio offers an additional treatment option for patients with cIAI and cUTI who have limited and, in some cases, no alternative therapeutic options.”
Dr Nick Kartsonis, Senior Vice President, Infectious Diseases and Vaccines at MSD, also commented: “Today’s announcement is a great example of Merck’s longstanding commitment to infectious diseases research and development, as we continue to search for novel ways to approach difficult-to-treat pathogens.”
Nexcella has announced that the US Food and Drug Administration (FDA) has granted orphan drug …
GSK has announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) …