(Reuters) - The U.S. Food and Drug Administration has approved Merck & Co Inc’s combination treatment for complicated forms of urinary tract and abdominal infections, the drugmaker said on Wednesday.
Recarbrio, approved for patients over 18 years of age, is a combination of a previously approved antibiotic imipenem-cilastatin and Merck’s relebactam.
Patients with urinary tract infections can develop complications if appropriate doses of the right antibiotics are not administered. At least 20% of complications are caused by multidrug-resistant bacteria that severely limit treatment options.
Health agencies around the world have been pushing for newer versions of antibiotics to address the growing threat of antimicrobial-resistant infections.
"It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient's infection," the FDA said in a statement. (reut.rs/2JKTXfD)
The approvals were based on limited clinical safety and efficacy data for Recarbrio, the company noted.
Relebactam is expected to bring in revenue of $50 million in 2020 and $150 million in 2024, Cowen & Co analyst Steve Scala said ahead of the approval.
The relebactam combination had been granted FDA’s ‘fast track’ status, which allows the agency to expedite the review process for certain drugs meant for serious conditions with unmet medical need.
Merck, which expects to make Recarbrio available later this year, already has an approved treatment, Zerbaxa, for complicated urinary tract infections and intra-abdominal infections.
The company added Zerbaxa to its portfolio through its acquisitihere of Cubist Pharmaceuticals in 2014.
Nearly 23,000 people in the U.S. die from urinary tract infection complications annually, according to the Centers for Disease Control and Prevention.
Reporting by Aakash Jagadeesh Babu and Manojna Maddipatla in Bengaluru; Editing by Shailesh Kuber