The US Food and Drug Administration (FDA) yesterday announced the approval of lefamulin, a novel antibiotic for the treatment of community-acquired bacterial pneumonia (CABP). The approval was for both oral and intravenous (IV) formulations of the drug, developed by Nabriva Therapeutics of Dublin.
Lefamulin is a first-in-class, semi-synthetic pleuromutilin antibiotic designed to inhibit the synthesis of bacterial protein, which is required for bacterial growth. It's indicated for treatment of CABP caused by the most common gram-positive and gram-negative bacteria associated with the disease, including Streptococcus pneumoniae, methicillin-susceptible Staphylococcus aureus, Mycoplasma pneumonia, and Haemophilus influenzae.
New antimicrobial resistance tool
"This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease," Ed Cox, MD, MPH, director of the FDA's Office of Antimicrobial Products, said in a news release. "For managing this serious disease, it is important for physicians and patients to have treatment options. This approval reinforces our ongoing commitment to address treatment of infectious diseases by facilitating the development of new antibiotics."
CABP is one of the most common infectious causes of illness and hospitalization, especially in the elderly. According to the Centers for Disease Control and Prevention, roughly 1 million people seek hospital care for CABP each year, and 50,000 people die from the disease. CABP is typically treated with macrolide and fluoroquinolone antibiotics.
Nabriva officials say lefamulin's novel method of action results in a low propensity for the development of resistance. They also believe that the oral and IV formulations of the drug, which will be sold under the brand name Xenleta, could position it to become a first-line treatment for CABP.
"Today'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," Nabriva CEO Ted Schroeder said in a company press release.
Safety, efficacy demonstrated in clinical trials
The approval was supported by two phase 3 clinical trials—known as LEAP 1 and LEAP 2—that evaluated the safety and efficacy of IV and oral lefamulin in 1,289 patients with CABP compared with moxifloxacin, a common first-line treatment. In LEAP 1, 5 to 7 days of IV/oral lefamulin demonstrated non-inferiority to 7 days of IV/oral moxifloxacin with or without linezolid. In LEAP 2, 5 days of oral lefamulin demonstrated non-inferiority to 7 days of oral moxifloxacin. The drug was generally well tolerated in both trials.
The most common adverse reactions reported in the trials were diarrhea, nausea, vomiting, reactions at the injection site, and elevated liver enzymes. The FDA said the drug should be avoided in patients who have irregular heart rhythms, those with known hypersensitivity to lefamulin or other pleuromutilin antibiotics, and pregnant women.
Available in US in 1 month
Lefamulin received the Qualified Infectious Disease Product (QIDP) designation from the FDA, which is given to antibacterial and antifungal products that treat serious or life-threatening infections. The aim of the QIDP designation, which was created by Congress in 2012 under the Generating Antibiotic Incentives Now (GAIN) Act, is to spur the development of new antibiotics for difficult-to-treat infections by granting drug makers an additional 5 years of marketing exclusivity.
The drug also received the FDA's Priority Review designation, which is granted for drugs that have the potential to offer advantages in clinical treatment.
Nabriva says it expects lefamulin will be available in the United States by mid-September. The IV formulation will have a wholesale price of $205 per day, while oral treatment will cost $275 per day.
See also:
Aug 19 FDA news release
Aug 19 Nabriva press release
