Merck MRK recently announced that the FDA has approved its new combination antibacterial injection, MK-7655A, which is a fixed combination of relebactam and imipenem/cilastatin.
The medicine, to be marketed by the trade name of Recarbrio, is approved for the treatment of adults with complicated urinary tract infections (cUTI ) and complicated intra-abdominal bacterial infections (cIAI) caused by certain susceptible gram-negative bacteria.
Limited clinical safety and efficacy data led to the approval of the drug for the above-mentioned indications. Recarbrio offers an additional treatment option for patients with cIAI and cUTI, who have limited and in some cases, no alternative therapeutic options.
Recarbrio received the FDA’s Qualified Infectious Disease Product (QIDP) designation for the treatment of cUTI and cIAI. QIDP is a designation granted to antibacterial or antifungal drugs for human use, intended to treat serious or life-threatening infections. This designation can boost the sales uptake of the drug. We remind investors that the new drug application (NDA) for Recarbrio received Priority Review designation from the FDA. Merck expects to launch the drug later this year.
Shares of the company have gained 8.2% so far this year compared with the industry ‘s growth of 2.3%. Stock was slightly up in pre-market trading following the news.