Telavancin Gains Expanded-Use Approval by the FDA


Staphylococcus aureus colonies on blood agarIn late June 2013 Telavancin, also known as the brand name antibiotic Vibativ, was approved by the FDA to treat bacterial pneumonia. Marketed by Theravance, Telavancin is an efficacious antibiotic treatment that has been previously approved in both the United States and Europe for bacterial and skin infections. This new approved indication for Telavancin is for the treatment of nosocomial pneumonia, which is a common, yet serious, lung infection afflicting many patients on ventilators. Europe had previously approved Telavancin for this indication, but the FDA expanded use approval for the U.S. occurred on June 21, 2013.  This expanded approval by the FDA is specific however to the use of Telavancin only for cases of bacterial pneumonia caused by staphylococcus aureus.

Telavancin is an injectable antibiotic treatment, administered in a hospital or clinic setting. As a powerful medication, Telavancin has proven to successfully treat gram-positive cases of Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus and vancomycin susceptible Enterococcus faecalis. Patients with kidney disease should be administered Telavancin with extreme caution, as this potent medication can be harmful to the kidneys.  Less severe side effects of Telavancin include chills, diarrhea, dizziness, appetite loss and stomach pain.

telavancinStudies regarding the use of Telavancin (Vibativ) for adult patients with hospital-acquired and ventilator-associated bacterial pneumonia, also called HABP/VABP, or bacterial pneumonia were very successful. After being used to treat over 1,500 patients with HABP/VABP caused by Staphylococcus aureus, Telavancin surpassed antibiotic Vancomycin in clinical cure rate evaluation. It should be noted that the use of Telavancin was considered for patients after alternative and typically standard treatments were explored and deemed unsuitable.  The aforementioned two double-blind and randomized Phase 3 studies were coined ATTAIN I and ATTAIN II, and involved approximately 1,503 patients, with 464 of these participants also being diagnosed with MRSA. The clinical trial participants were given either receive either 10 milligrams/kilograms of Telavancin intravenously one time daily or 1 gram of Vancomycin every 12 hours intravenously. Telavancin proved to be just as effective as Vancomycin.

LGM Pharma provides the API Telavancin CAS# 372151-71-8 for research and development purposes. Clients can be assured of continuous support throughout the R&D process, as well as quality API products.

 

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