US FDA Approves Merck & Co., Inc. (NYSE:MRK) Zinplava, Keytruda

Merck & Co., Inc.

The US Food and Drug Administration (FDA) has recently approved the Zinplava (bezlotoxumab) injection 25 mg/mL of Merck & Co., Inc. (NYSE:MRK). Consequently, the company aims to launch the injection in the market by early 2017.

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Similarly, the US FDA has also approved the company’s anti-programmed-death-receptor-1 (anti-PD-1) therapy, Keytruda (pembrolizumab).


Zinplava, a monoclonal antibody, has been approved to minimize the recurrence of Clostridium difficile infection (CDI) among adult patients who are being administered with antibacterial treatment and are at greater risks for CDI recurrence. It is important to note that Zinplava is not an antibacterial drug and not directly and primarily intended to treat CDI.

CDI is a bacterial infection caused by toxin-producing bacteria. Common symptoms of the condition include fever, mild-to-severe diarrhea, and abdominal pain.

“For generations, Merck has been steadfast in its commitment to fighting infectious diseases— and that commitment continues today,” elaborated Nicholas Kartsonis, Ph.D., Merck Research Laboratories Vice President (VP) of Clinical Development, Infectious Diseases.

The adverse reactions associated with Zinplava treatment include heart failure, which can be common among patients with a history of congestive heart failure (CHF). More deaths in the clinical trial program have also been associated with patients who have a CHF history.


Keytruda has been approved for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients whose tumors have high PD-L1 expression. Currently, it is the only anti-PD-1 drug approved for the said indication.

Specifically, Keytruda has been approved for administration of 200 mg every three weeks among metastatic NSCLC patients until disease progression or up to 24 months without disease progression.

According to Roger Perlmutter, M.D., Ph.D., Merck Research Laboratories President, Keytruda has generally improved survival rates among metastatic NSCLC patients compared to traditional chemotherapy. Consequently, its approval can potentially enhance the treatments and lifestyle of metastatic NSCLC patients.

However, there can also be some adverse reactions resulting from Keytruda administration. These include colitis, endocrinopathies, hepatitis, nephritis, and pneumonitis. Depending on the severity of these occurrences, Keytruda medication must immediately he discontinued.

Merck has declined 0.74% on Monday, closing at $60.75.

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