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Merck's Antibiotic Recarbrio Gets FDA Nod for New Indication

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Merck & Co., Inc. MRK announced that the FDA has approved the supplemental new drug application (sNDA) for its new antibacterial injection Recarbrio for a new indication. Recarbrio is now approved to treat adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain susceptible Gram-negative microorganisms.

Merck filed the sNDA seeking approval for Recarbrio to address the HABP/VABP indication in February.

The sNDA was based on the results of the pivotal phase III RESTORE-IMI 2 study. In the same, Recarbrio met both the primary and key secondary endpoints by demonstrating non-inferiority to PIP/TAZ in a 28-day all-cause mortality and clinical response at early follow-up, respectively.

Recarbrio is a fixed combination of relebactam and imipenem/cilastatin. It was approved for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by certain susceptible gram-negative bacteria in July 2019.

Shares of Merck have declined 9.6% in the year so far compared with the industry’s decrease of 1.3%.


We note that 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 drug’s sales in the days ahead.

Merck’s antibacterial medicine Zerbaxa is also approved for HABP/VABP. Zerbaxa, a combination of ceftolozane and tazobactam, is also marketed for some complicated urinary tract infections.

Zacks Rank and Stocks to Consider

Merck currently has a Zacks Rank #3 (Hold). Better-ranked stocks in the large-cap pharma sector include Eli Lilly and Company LLY, AbbVie Inc. ABBV and AstraZeneca AZN. While Eli Lilly and AbbVie currently sport a Zacks Rank #1 (Strong Buy), AstraZeneca presently holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Eli Lilly’s earnings estimates have been revised 0.6% upward for 2020 and 1% for 2021 over the past 60 days. The stock has gained 13.6% year to date.

AbbVie earnings estimates have been revised 14.2% upward for 2020 and 6.6% for 2021 over the past 60 days. The stock has inched up 5.9% year to date.

AstraZeneca’s earnings estimates have moved 0.5% north for 2020 and 0.8% for 2021 over the past 60 days. The stock has rallied 8% year to date.

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Click to get this free report AstraZeneca PLC (AZN) : Free Stock Analysis Report Merck Co., Inc. (MRK) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research