24. Xenleta

Xenleta (lefamulin)
(Nabriva)

Active ingredient: lefamulin
Disease: community-acquired bacterial pneumonia
Peak sales estimate: n/a
Approved: Aug. 19, 2019
Company: Nabriva Therapeutics

The scoop: With antibiotic-resistant bacteria on the rise, healthcare providers are looking for novel solutions from drugmakers. In August, Nabriva stepped up to the plate with FDA approval for its Xenleta, a novel antibiotic to treat community-acquired bacterial pneumonia (CABP). Xenleta is the first in a new class of antibiotics called pleuromutilins, which target a different protein synthesis binding site than older competitors. Nabriva marketed Xenleta, approved in both an oral and intravenous formulation, as a new answer for CABP, which affects around 5 million Americans each year, the Irish drugmaker said. The drug’s approval followed the second of two phase 3 trials that hit its primary endpoint in May 2018. Nabriva’s second trial compared an oral, five-day Xenleta regimen to seven days of treatment with approved antibiotic moxifloxacin in patients with moderate CABP. The trial associated the regimens with identical early clinical response rates of 90.8%, resulting in it hitting its noninferiority primary endpoint. –– Kyle Blankenship

24. Xenleta