The Food and Drug Administration (FDA) has accepted a supplemental New Drug Application from Theravance Biopharma for its drug VIBATIV (telavancin), which combats hospital-acquired and ventilator-associated bacterial pneumonia.
Theravance hopes to expand the label to include the treatment of Staphylococcus aureus, including strains that are resistant to most antibiotic treatments including Methicillin, known as MRSA.
“New data presented at recent scientific conferences has demonstrated greater in vitro activity for VIBATIV against methicillin-resistant Staphylococcus aureus (MRSA) and other difficult-to-treat clinical pathogens as compared to antibiotics such as vancomycin, daptomycin and linezolid,” Tim Brons, executive vice president of life sciences communication for Vida Strategic Partners, said.
MRSA is responsible for 80,000 invasive infections and 11,285 related deaths occur every year according to the Centers for Disease Control. Staph infections also cause bacterial pneumonia and complicated skin and skin structure infections.
“The potent in vitro activity of VIBATIV against Staphylococcus aureus supported the product’s approval in both (pneumonia and skin infections) caused by Gram-positive bacteria including Staphylococcus aureus,” Brons said.
VIBATIV is also important because of its effectiveness against the typically hard to treat MRSA infection. VIBATIV kills bacteria by inhibiting cell wall biosynthesis and by disrupting membrane barrier function, a combination that makes it a strong tool in the arsenal of MRSA therapies. Along with its in vitro potency, VIBATIV surpasses other treatments in terms of convenience, requiring less-frequent doses and no need for serum monitoring.
“With the crisis of antibiotic resistance continuing to grow more acute, there is an urgent need for differentiated antibiotic products that are able to address difficult-to-treat bacteria that have limited or no susceptibility to currently available antibiotics,” Brons said. “We believe that VIBATIV demonstrates a number of critical attributes that may offer key advantages in the fight against antibiotic resistance.”
Those factors include the dual-method approach to combating infections, the in vitro potency, reliably maintained drug levels, and continued efficiency in the face of more bacteria becoming resistant to other approaches.
Theravance is in Phase 3 trials to determine VIBATIV’s effectiveness for patients with Staphylococcus aureus infections and is expected to finish in 2017.