Merck's Antibiotic Recarbrio Gets FDA Nod for Infections

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.

Last month, Merck also received FDA approval for the label expansion of its antibacterial medicine, Zerbaxa, in two types of pneumonia infections — hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). Zerbaxa, a combination of ceftolozane and tazobactam, was initially marketed for some complicated urinary tract infections.

Merck & Co., Inc. Price

 

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Zacks Rank and Other Stocks to Consider

Merck currently has a Zacks Rank #2 (Buy).

Some other similar-ranked stocks in the large-cap pharmaceutical sector include Novartis AG NVS, Sanofi SNY and Roche Holding AG RHHBY. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Novartis’ earnings per share estimates increased from $5.00 to $5.01 for 2019 and from $5.54 to $5.60 for 2020 over the past 60 days. Share price of the company has increased 20.8% year to date.

Sanofi’s earnings per share estimates have moved up from $3.23 to $3.25 for 2019 and from $3.48 to $3.50 for 2020 in the past 60 days.

Roche’s earnings per share estimates have moved up from $2.45 to $2.47 for 2019 and from $2.44 to $2.52 for 2020 in the past 60 days. Share price of the company has increased 10.5% year to date.

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