FDA Approves Pneumonia Treatment
The agency approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.
On Aug. 19, 2019, FDA announced it has approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia (CABP). Xenleta was approved after receiving Qualified Infectious Disease Product designation for products designed to treat serious, life-threatening infections.
According to FDA, community-acquired pneumonia develops outside of a hospital setting and can range from severe to mild. Approximately 50,000 people die from CABP and one million people are hospitalized with the infection each year in the United States.
Xenleta was evaluated in two clinical trials with a total of 1289 patients with CABP, which compared the drug to moxifloxacin with or without linezolid. Patients treated with Xenleta had similar rates of clinical success as those treated with moxifloxacin with or without linezolid, according to FDA. Common adverse reactions include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting.
The agency advises that there are risks involved when taking the new medication. “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,” FDA stated in a press release. Patients with a known hypersensitivity to lefamulin or any other members of the pleuromutilin antibiotic class, or any of the components of Xenleta, should not use Xenleta. The agency also advises that pregnant women and women who could become pregnant should be advised of the risks of using Xenleta.
“This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease,” said Ed Cox, MD, MPH, director of FDA’s Office of Antimicrobial Products, in the press 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.”
Source: FDA
Shilpa Medicare Launches ‘Hybrid CDMO’ at DCAT Week 2025
March 17th 2025This model is being positioned by Shilpa as a dual approach that offers comprehensive discovery, clinical, and commercial outsourcing services in addition to commercially ready, “off-the-shelf” novel formulations for b2b licensing.
