Merck speeds up drug-submission plans for Hep C, lung cancer: WSJ

[January 12, 2015] (Reuters) - Merck & Co has put on fast track its plans to submit new drugs for hepatitis C and lung cancer for regulatory approval, in an attempt to close the gap with competitors in two lucrative segments, the Wall Street Journal reported.

The drugmaker will file an application midyear for U.S. regulatory approval to expand the use of its new cancer immunotherapy Keytruda to include the treatment of non-small-cell lung cancer, the most common form of the deadly disease, the Journal reported. (http://on.wsj.com/1B8p4YM)

Merck also plans to file an application in the first half of this year for FDA approval to market grazoprevir/elbasvir, a new two-drug, single-pill combination to treat the liver disease hepatitis C, the newspaper said.

Merck said in November that it planned to submit the New Drug Application for grazoprevir/elbasvir sometime in 2015.

"The tempo has changed. What we are doing is focusing our efforts more profoundly, increasing the speed at which we complete things," the Journal quoted Roger Perlmutter, president of Merck Research Laboratories, as saying.

Reuters could not immediately reach Merck for comment outside regular U.S. business hours.

Keytruda (pembrolizumab) belongs to a new class of drugs called PD-1 inhibitors that have generated great enthusiasm in the medical community. They work by blocking a mechanism tumors use to camouflage themselves from the immune system, allowing it to recognize and attack the cancer.

The U.S. Food and Drug Administration approved Keytruda last year to treat advanced melanoma - the deadliest form of skin cancer - making it the first drug from the PD-1 class to reach the U.S. market.

Rival drugmaker Bristol-Myers Squibb Co said on Sunday the independent data monitoring committee concluded that a late-stage study evaluating its skin-cancer drug Opdivo versus docetaxel in previously treated patients with advanced, squamous cell non-small cell lung cancer met its endpoint.

(Reporting by Supriya Kurane in Bengaluru; Editing by Gopakumar Warrier)

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