40. Nuzyra

(Paratek Pharmaceuticals)

Active ingredient: omadacycline 
Disease: Community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections
Peak sales estimate: $500 million 
Approved: Oct. 3 
Company: Paratek Pharmaceuticals 

The scoop: Paratek’s omadacycline sailed through phase 3 before winning an FDA green light for two types of infection: community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A pair of pivotal trials enrolled more than 700 patients each and pitted omadacycline against existing antibiotics in both indications. In fact, the phase 3 ABSSSI study was the first time a pivotal trial has demonstrated an oral-only regimen of omadacycline can show comparable efficacy to established antibiotics. Previous phase 3 studies in ABSSSI and CABP also met their primary endpoints, but patients in those trials received an intravenous formulation of the drug before transitioning to the oral version. Leerink analyst Ami Fadia pegged peak sales for Nuzyra at $500 million, with roughly a 50-50 split between the two indications. — Amirah Al Idrus 

40. Nuzyra

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