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Merck's Pediatric Filings for Dificid Get FDA's Priority Review

Zacks Equity Research

Merck & Co., Inc. MRK announced that the FDA has accepted its new drug application (NDA) and a supplemental NDA (sNDA) for its antibacterial medicine Dificid (fidaxomicin) to treat Clostridium difficile infections (CDI) in children aged six months and above.

The NDA is seeking approval for an oral suspension formulation of Dificid, which is presently available in tablet form. While the sNDA eyes an approval for the pediatric indication of Dificid tablets and the oral suspension.

With the FDA granting a priority review to both the NDA and the sNDA, a decision from the regulatory body is expected on Jan 24, 2020.

The sNDA for Dificid tablets and oral suspension was based on data from the phase III SUNSHINE study.

Shares of Merck have increased 6.8% so far this year against the industry’s decrease of 1.4%.

In a separate press release, Merck announced that China's National Medical Products Administration has approved Keytruda (pembrolizumab) as a monotherapy for the first-line treatment of patients with locally advanced/metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 with no EGFR or ALK genomic tumor aberrations.

This label expansion nod by the Chinese regulatory agency was based on overall survival (OS) data from the phase III KEYNOTE-042 study and an extension of the global study, which evaluated Keytruda as a monotherapy for the given patient population in China.

In the extension study, treatment with Keytruda as a monotherapy led to a statistically significant improvement in OS compared with chemotherapy in the above subject population. Per the company, Keytruda monotherapy also demonstrated a survival benefit compared with chemotherapy alone across histologies in patients whose tumors express PD-L1 in at least 1% of tumor cells.

Keytruda is already approved in China in combination with chemotherapy in the first-line setting for NSCLC.

We remind investors that Keytruda is a key contributor to Merck’s sales growth. The drug generated sales of $4.9 billion in the first six months of 2019, reflecting a massive 58.1% surge year over year.

Keytruda sales are gaining particularly from a strong momentum in the first-line lung cancer indication after being the first anti-PD-1 therapy approved in the first-line setting.

Meanwhile, Merck is collaborating with several companies including Amgen AMGN, Incyte INCY, Pfizer PFE and Glaxo separately for the evaluation of Keytruda in combination with other regimens.

We believe that Keytruda has strong future growth prospects based on increased utilization, nod for new indications and expectation of additional approvals worldwide.

Zacks Rank

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

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