The FDA’s approval of Xenleta is the first of its kind in almost two decades and will treat community-acquired bacterial pneumonia.
Shares of Nabriva (NASDAQ:NBRV) spiked in after-hours trading on Monday (August 19) when the company scored its first ever US Food and Drug Administration (FDA) approval for its antibiotic to treat community-acquired bacterial pneumonia (CABP).
Called Xenleta, it is the first approval of its kind from the FDA in almost two decades. Xenleta, also known as lefamulin, can be injected intravenously or taken orally in a new way that has been greenlit by the FDA and stops bacteria from reproducing.
The company’s shares were halted midway through the afternoon and closed at US$2.21. In after-hours trading, Nabriva’s share price rose by 25.53 percent to reach US$2.77 as of 6:13 p.m. EDT.
“(Monday’s) approval of Xenleta is a significant breakthrough in the collective fight against the growing threat of antimicrobial resistance and provides a desperately needed IV and oral empiric monotherapy treatment option for adults with CABP,” Ted Schroeder, CEO of Nabriva, said in a press release.
Schroeder added that the company began developing Xenleta over 10 years ago and it now represents an FDA-designated first-in-class type of antibiotic called pleuromutilins.
CABP is pneumonia that develops outside of the hospital and is characterized as a lung infection. Data from the Centers for Disease Control and Prevention estimates that 1 million people per year are hospitalized in the US from CABP, while 50,000 people die from the illness.
The FDA’s approval of Xenleta comes based off results from two global Phase 3 trials in which 1,289 patients with CABP participated. According to the FDA, the safety and efficacy of Xenleta was evaluated to another antibiotic called moxifloxacin with or without linezolid.
Patients who took Xenleta demonstrated similar improvement rates compared to those who took moxifloxacin. Common side effects reported were diarrhea, nausea and vomiting, among others.
Both methods of Xenleta were given qualified infectious disease product and fast track designation by the FDA and are expected to be available at specialty distributors across the US by mid-September. According to the company’s press release, the antibiotic will have a daily wholesale acquisition price of US$205 per IV treatment and US$275 per oral treatment.
“This new drug provides another option for the treatment of patients with (CABP), a serious disease,” Ed Cox, MD, director of the FDA’s office of antimicrobial products, said in the FDA’s announcement. “This approval reinforces our ongoing commitment to address treatment of infectious diseases by facilitating the development of new antibiotics.”
Nabriva’s FDA approval for Xenleta comes on the heels of its plans to resubmit its new drug application for Contepo to the FDA in early Q4 of this year. Contepo is an injection to treat urinary tract infections, in particular acute pyelonephritis.
According to the announcement, no new clinical or non-clinical data has been asked for by the FDA, nor were there any issues relating to the safety and efficacy of Contepo.
In an interview with Reuters, Wedbush analyst Robert Driscoll said he expects sales of Xenleta to reach US$267 million by the end of 2025.
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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.