19. Zinplava


Active ingredient:  Bezlotoxumab
Disease: Clostridium difficile infection
Peak sales estimate: $350 million
Approved: Oct. 23
Company: Merck

The scoop: Merck picked up a nod from the FDA for its Zinplava C. diff anti-infective in late October, capping a process that saw the regulator delay its approval in July over concerns about trial data. At that time, an FDA panel demanded more data from Merck, delaying its PDUFA date until October, citing shortcomings regarding the size of the trial, which garnered particular apprehension as the C. diff population is large. But the final decision gave Merck a much-needed boost to its anti-infectives line with its feet to the fire on blockbuster antibiotic Cubicin (acquired when the company bought Cubist Pharmaceuticals in 2015) as that drug faces an onslaught of generics. The new drug isn’t expected to come anywhere near the numbers Cubicin raked in at $649 million in this year’s first half, but experts predicted 2020 sales of Zinplava to reach $350 million. Merck picked up the candidate from soon-to-be-BMS-owned Medarex in 2009. —Michael Gibney

19. Zinplava

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