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Merck's Antibiotic Zerbaxa Gets FDA Nod for New Indication

Merck & Co., Inc. MRK gained FDA approval for a supplemental new drug application looking for label expansion of its antibacterial medicine, Zerbaxa for two types of pneumonia infections.

Zerbaxa, a combination of ceftolozane and tazobactam, is presently marketed for some complicated urinary tract infections.

With the latest FDA approval, Zerbaxa (3g dose) can now be prescribed for the treatment of patients 18 years and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). 

The supplemental new drug application was filed based on data from a pivotal phase III study, which evaluated critically ill and ventilated patients with pneumonia. Results from the study demonstrated non-inferiority of Zerbaxa to meropenem, the active comparator, thereby meeting the study’s primary endpoint

Merck’s shares have performed well this year so far. Merck’s shares have risen 5% this year so far against the industry’s decrease of 2.2%.

 

 

Zerbaxa was added to Merck’s portfolio with the 2015 acquisition of Cubist Pharmaceutical and is part of its hospital acute care portfolio. Other popular products in Merck’s hospital acute care portfolio are Noxafil, Cubicin and Bridion.

Merck has another anti-bacterial candidate, MK-7655A, whose NDA is under review with the FDA. MK-7655A is a fixed combination of relebactam with imipenem/cilastatin. Merck is looking to get MK-7655A approved for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by certain susceptible Gram-negative bacteria. The FDA action on MK-7655A is expected on Jul 16.

Merck currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here

Other top-ranked large drug stocks include AbbVie ABBV, Bristol-Myers Squibb Company BMY and Roche RHHBY. While Bristol-Myers sports a Zacks Rank #1, AbbVie and Roche have a Zacks Rank #2.

AbbVie’s earnings estimates increased 1.5% for 2019 and 1.3% for 2020 over the last 60 days. The company delivered positive earnings surprise in three of the trailing four quarters, with the average beat being 2.58%.

Bristol-Myers’ earnings estimates increased 5.2% for 2020 over the last 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with the average being 11.85%.

Roche’s earnings estimates increased 2.1% for 2019 and 1.3% for 2020 over the last 60 days. The company’s shares have increased 9.4% this year so far.

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