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EU & US At Odds Over Merck’s Keytruda

Decisions Show How Regulators Can Differ Over Same Data

 
• By Ian Schofield

EU and US regulators have opposing views when it comes to Merck's applications for a new indication and new dosing schedule for the company's successful PD-1 inhibitor Keytruda.

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Regulators sometimes take different decisions on the same drug • Source: Shutterstock

Contrasting decisions by the European Medicines Agency and the US Food and Drug Administration relating to Merck & Co. Inc.’s blockbuster immunotherapy product, Keytruda (pembrolizumab), have again illustrated the potential for the two regulators to disagree over whether a new product, indication or dosing schedule should be approved.

At the end of January, the EMA announced that Merck Sharp & Dohme, as Merck is known in Europe, had...

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