Merck Discontinues Recarbrio Antibiotic in US Market

Merck pulled Recarbrio from the US market following a portfolio review, while the drug remains available in the United Kingdom and the European Union.

The US discontinuation of Recarbrio affects a drug approved by the Food and Drug Administration in 2019 for adults with complicated urinary tract infections and intra-abdominal infections who lacked alternative options. Regulatory approvals expanded in 2020 for hospital-acquired and ventilator-associated bacterial pneumonia, followed by a pediatric expansion in 2025. Developed to target multidrug-resistant pathogens carrying beta-lactam-disabling resistance mechanisms like Klebsiella pneumoniae carbapenemase, the drug combines imipenem-cilastatin with relebactam. Merck confirmed the voluntary withdrawal of Recarbrio from the US market as part of an ongoing portfolio review, emphasizing that the move is unconnected to product safety or quality issues.

Clinicians Assess Impact on Resistant Pathogens

Amesh Adalja, an infectious disease physician and senior scholar with the Johns Hopkins University Center for Health Security, described the resulting clinical gap as immediate but narrow. Medical experts disagree on how significantly the loss of the drug will affect patient care. A Merck spokesperson stated that alternative therapies remain available for approved indications and advised patients to consult healthcare providers.

For KPC-producing CRE, the resistance relebactam was designed to overcome, we still have drugs like ceftazidime-avibactam, meropenem-vaborbactam, and cefiderocol.

Amesh Adalja, MD, infectious disease physician and senior scholar with the Johns Hopkins University Center for Health Security, via CIDRAP

Other clinicians view the departure with indifference.

Aaron Kesselheim, a clinician and regulatory practice expert at Harvard Medical School, offered a similar assessment. He noted that Recarbrio saw rare usage partly due to insufficient evidence demonstrating a clear clinical advantage over cheaper antibiotics, pointing out that clinical trials lacked patients carrying carbapenem-resistant bacteria, with most participants likely responding to imipenem alone.

Economic Pressures Drive Antibiotic Market Challenges

Henry Skinner, chief executive of the AMR Action Fund, warned that the market reality threatens future innovation, as reserve antibiotics sit on shelves for extended periods and generate minimal revenue because stewardship programs require hospitals to reserve new drugs for severe cases.

Petri dish growing bacteria — Photo: insights.citeline.com

Skinner highlighted the specific risk to pediatric antibiotic development. Citing a 2025 study in the journal Antibiotics, he noted that smaller developers completed only 10% of required pediatric post-approval studies and received no pediatric approvals. Praising Merck for fulfilling the extensive work required to expand Recarbrio’s label for children weighing as little as 2 kilograms, Skinner questioned who will generate necessary pediatric evidence if large companies exit the market.

International Sales Continue Ahead of Payment Reforms

Recarbrio remains available in the United Kingdom and the European Union while exiting the US. Merck explained that availability decisions are made market by market based on local patient needs, demand, supply, and regulatory requirements.

The United Kingdom piloted a subscription model in 2020 that pays companies a fixed annual fee based on a drug’s value rather than prescription volume. In the United States, lawmakers have pursued a federal subscription model known as the PASTEUR Act, which would establish a $6 billion (approximately £4.5 billion) federal payment mechanism for novel antibiotics and has not yet passed Congress.