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Merck's (MRK) Chronic Cough Drug Gets CRL From FDA

Merck MRK announced that the FDA has issued a complete response letter (CRL) to its new drug application (“NDA”) for its oral P2X3 receptor antagonist, gefapixant.

The NDA is seeking approval for the drug to treat refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.

Per the CRL, the FDA has asked for additional information from Merck regarding the measurement of gefapixant’s efficacy. The CRL was not related to any safety concerns raised by the FDA.

Shares of Merck were down 1.4% in intra-day trading on Jan 24, following the above news. In fact, the stock has declined 1.8% against the industry’s 8.1% rise in the trailing 12 months.

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Following the receipt of CRL, Merck plans to hold a meeting with the FDA to discuss the next steps that are needed to be taken to secure approval in the given indication. The FDA accepted Merck’s NDA for gefapixant last March.

Per Merck, approximately 5% of adults in the United States suffer from chronic cough. Management estimates that a fraction of patients with chronic cough suffer from RCC or UCC. Presently, there are no approved treatments for RCC or UCC indication in the country.

In the same press release, Merck also announced that gefapixant secured approval for RCC or UCC in Japan last week. The drug will be marketed under the trade name Lyfnua (45 mg tablets).

We note that quite a few companies like Bayer BAYRY and Bellus Health BLU are also evaluating their own candidates targeting RCC indication, which can pose stiff competition to Merck’s gefapixant, if approved and launched.

Last month, shares of Bellus Health surged after it announced that the phase IIb SOOTHE study evaluated three different doses of its RCC candidate, BLU-5937, against placebo. Bellus’ SOOTHE study achieved statistical significance in its primary endpoint of placebo-adjusted change in the 24-hour cough frequency from baseline to day 28 collected with a cough recorder.

Bellus Health plans to hold an end of phase II meeting in second-quarter 2022 to discuss plans of initiating a phase III program by second-half 2022.

Bayer is also evaluating its own investigational P2X3 receptor antagonist, eliapixant, in RCC indication.

Last September, Bayer announced encouraging data from a phase IIb study, which evaluated eliapixant in RCC patients. Data from the phase IIb study demonstrated that treatment with Bayer’s eliapixant (75 mg twice daily) led to a statistically significant reduction in the 24-hour cough count compared to placebo over a 12-week treatment period.

Zacks Rank & Key Pick

Merck carries a Zacks Rank #3 (Hold) at present. A better-ranked stock in the same sector is Pfizer PFE, which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Pfizer’s earnings per share estimates for 2022 have increased from $4.00 to $5.80 in the past 60 days. Shares of Pfizer have risen 38.3% in the past year.

Earnings of Pfizerbeat estimates in three of the last four quarters while missing the mark on another occasion, delivering a surprise of 10.9%, on average.

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