SILVER SPRING, Md.,
Aug. 19, 2019 /PRNewswire/ -- The
U.S. Food and Drug Administration today approved Xenleta
(lefamulin) to treat adults with community-acquired bacterial
pneumonia.
"This new drug provides another option for the treatment of
patients with community-acquired bacterial pneumonia, a serious
disease," said Ed Cox, M.D., M.P.H.,
director of FDA's Office of Antimicrobial Products. "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."
Community-acquired pneumonia occurs when someone develops
pneumonia in the community (not in a hospital). Pneumonia is a type
of lung infection that can range in severity from mild to severe
illness and can affect people of all ages. According to data from
the Centers from Disease Control and Prevention, each year in
the United States, about one
million people are hospitalized with community-acquired pneumonia
and 50,000 people die from the disease.
The safety and efficacy of Xenleta, taken either orally or
intravenously, was evaluated in two clinical trials with a total of
1,289 patients with CABP. In these trials, treatment with Xenleta
was compared to another antibiotic, moxifloxacin with or without
linezolid. The trials showed that patients treated with Xenleta had
similar rates of clinical success as those treated with
moxifloxacin with or without linezolid.
The most common adverse reactions reported in patients taking
Xenleta included diarrhea, nausea, reactions at the injection site,
elevated liver enzymes and vomiting. Xenleta has the potential to
cause a change on an ECG reading (prolonged QT interval). Patients
with prolonged QT interval, patients with certain irregular heart
rhythms (arrhythmias), patients receiving treatment for certain
irregular heart rhythms (antiarrhythmic agents), and patients
receiving other drugs that prolong the QT interval should avoid
Xenleta. In addition, Xenleta should not be used in patients with
known hypersensitivity to lefamulin or any other members of the
pleuromutilin antibiotic class, or any of the components of
Xenleta. Based on findings of fetal harm in animal studies,
pregnant women and women who could become pregnant should be
advised of the potential risks of Xenleta to a fetus. Women who
could become pregnant should be advised to use effective
contraception during treatment with Xenleta and for two days after
the final dose.
Xenleta received FDA's Qualified Infectious Disease Product
(QIDP) designation. The QIDP designation is given to antibacterial
and antifungal drug products intended to treat serious or
life-threatening infections under the Generating Antibiotic
Incentives Now (GAIN) title of the FDA Safety and Innovation Act.
As part of QIDP designation, Xenleta was granted Priority
Review under which the FDA's goal is to take action on an
application within an expedited time frame.
The FDA granted the approval of Xenleta to Nabriva
Therapeutics.
A key global challenge the FDA faces as a public health agency
is addressing the threat of antimicrobial-resistant infections.
Among the FDA's other efforts to address antimicrobial resistance,
is the focus on facilitating the development of safe and effective
new treatments to give patients more options to fight serious
infections.
More information:
- Antimicrobial Resistance Information from FDA
- CDC - Pneumonia
- CDC – Pneumonia Can Be Prevented – Vaccines Can Help
- NIH/NHLBI – Pneumonia
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
Media Inquiries: Alison
Hunt, 240-402-0764, alison.hunt@fda.hhs.gov
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SOURCE U.S. Food and Drug Administration