The US Food and Drug Administration (FDA) has accepted the filing of Theravance Biopharma Inc's supplemental New Drug Application (sNDA) for Vibativ (telavancin). The sNDA seeks to expand the current label for Vibativ to include treatment of cases of concurrent Staphylococcus aureus bacteremia in both of the antibiotic's currently approved indications in the United States.
Vibativ for injection is approved in the US for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable. In addition, Vibativ is approved in the US for the treatment of adult patients with complicated skin & skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.
Bacteremia is the presence of bacteria in the bloodstream and can occur spontaneously or in the presence of other infections. Bacteremia continues to represent a significant unmet medical need. Concurrent bacteremia, which in its most serious form is fatal, occurs when bacteria spreads from its initial infection site and enters the bloodstream. As a secondary infection, it introduces significant challenges to the treatment of the primary infection, as well as the concurrent bacteremia itself.
"Both primary bacteremia and concurrent bacteremia continue to increase in incidence and severity and this growing health threat is compounded by the relative lack of effective treatments for these infections. To address this important unmet need, we are taking a proactive approach to evaluating the potential of Vibativ in this area. This is evidenced not only by today's sNDA milestone but also our ongoing phase 3 registrational study of telavancin in Staphylococcus aureus bacteremia," said Rick E Winningham, chairman and chief executive officer of Theravance Biopharma.
"We are pleased with this action by FDA regarding the sNDA and look forward to working with the agency to help advance the goal of expanding treatment options for patients battling both primary and concurrent bacteremia."
The sNDA submission was based on the combined data from Theravance Biopharma's previously conducted pivotal trials of Vibativ in its two approved indications -- cSSSI (ATLAS I and ATLAS II) and HABP/VABP (ATTAIN I and ATTAIN II). The trials were large, multi-center, multinational, double-blind, randomized phase 3 clinical studies enrolling and treating 3,370 adult patients, including a portion of patients with concurrent bacteremia. Importantly, these studies involved two of the largest cohorts of patients ever studied in these diseases and included one of the largest cohorts of patients with MRSA infections studied to date.
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target of Q2 2016 to complete its review of the sNDA.
Separately, Theravance Biopharma is currently conducting a phase 3 registrational study of telavancin in patients with Staphylococcus aureus bacteremia. The trial is a multi-center, randomized, open-label study that is enrolling approximately 250 adult patients with confirmed MSSA or MRSA bacteremia at about 70 clinical sites in the US and around the world. Researchers are evaluating telavancin in treating these patients as compared to standard therapies such as vancomycin, daptomycin and anti-staphylococcal penicillins. The trial is expected to be completed in 2017.
Vibativ is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in vitro potency and a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. The drug's proven efficacy against difficult-to-treat Gram-positive infections has been demonstrated in several large, multinational registrational studies, which involved one of the largest cohorts of patients with MRSA infections studied to date. Additionally, there is extensive and well-documented evidence of the drug's in vitro potency and in vivo activity against a broad collection of gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.
Vibativ was discovered internally in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus and other Gram-positive bacteria, including MRSA. Vibativ is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in vitro potency and a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. Vibativ for injection is approved in the US for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable. In addition, Vibativ is approved in the US for the treatment of adult patients with complicated skin & skin structure infections (cSSSI) caused by susceptible isolates of gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.
In addition to the US, Vibativ is approved for use in several markets around the world including Europe, Canada and Russia. The specific approved indications in these markets vary by region. Theravance Biopharma plans to market Vibativ outside the US through a network of partners. To date, the company has secured partners for Vibativ in the following geographies -- Europe, Canada, Middle East, North Africa, Israel, Russia, and China.
The most common adverse reactions (greater than or equal to 10 per cent of patients treated with Vibativ ) were diarrhea, taste disturbance, nausea, vomiting, and foamy urine.