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Merck's Anti-PD-1 Drug Keytruda First to be Launched in US

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The FDA approved Merck & Co. Inc.’s (MRK) advanced melanoma treatment, Keytruda. The drug is approved in the U.S. at a dose of 2 mg/kg every three weeks for the treatment of patients suffering from unresectable or metastatic melanoma and whose disease progressed after treatment with Bristol-Myers Squibb Company’s (BMY) Yervoy (ipilimumab).

Merck mentioned in its press release that Keytruda becomes the first anti-PD-1 therapy to gain approval in the U.S. Merck intends to launch the immuno-oncology drug shortly in the U.S.

Merck received accelerated approval for Keytruda based on tumor response rate and durability of response. Accelerated approval is granted by the FDA to drugs that are meant to treat serious conditions and fulfil an unmet medical need based on a surrogate or an intermediate clinical endpoint. Keytruda enjoys Breakthrough Therapy designation in the U.S. for advanced melanoma.

The drug is also under review in the EU (read more: Will Merck's Anti-PD-1 Therapy be the First to Launch?).

Merck is evaluating Keytruda for more than 30 types of cancer alone and in combination with other therapies. Merck expects to have over 24 clinical trials on Keytruda by the end of the year.

We are encouraged by the pace of Merck’s product approvals over the last few quarters. Keytruda will significantly boost its portfolio. However, the highly lucrative immune-oncology market is targeted by several companies. Some major players in this market include Roche (RHHBY).

In a separate development, Merck received Qualified Infectious Disease Product (:QIDP) and Fast Track designations from the FDA for relebactam. Relebactam is being developed for the treatment of complicated urinary tract infections, complicated intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.

The QIDP designation will allow an extra five years of exclusivity under the Hatch-Waxman Act apart from other incentives. Relebactam will also be reviewed on a priority basis by the FDA once filed.

Merck is currently evaluating the candidate in a phase II study for the treatment of complicated urinary tract infections and complicated intra-abdominal infections. The company also plans to start phase III studies on relebactam in combination with imipenem/cilastatin next year.

Merck is a Zacks #3 (Hold) stock. A better-ranked stock in the health care sector is Allergan (AGN) – a Zacks Rank #1 (Strong Buy) stock.

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