Theravance Inc. (THRX) announced that it has received from the U.S. Food and Drug Administration a letter indicating that Theravance's response to the November 2009 Complete Response letter for the telavancin New Drug Application or NDA for the treatment of nosocomial pneumonia or NP is incomplete and that the review clock will not start until the FDA receives a complete response.
Telavancin is a bactericidal, once-daily injectable investigational antibiotic for the treatment of NP caused by Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA).
VIBATIV (telavancin) is approved in the United States and in Canada for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group.
The letter also suggested that the study population should contain patients with a high likelihood of having the disease of interest. Therefore, the inclusion criteria for enrolled patients should include evidence of a new or progressive infiltrate on chest radiograph with at least two of the following features: fever > 38 degrees C, leukocytosis or leukopenia, and purulent lower respiratory tract secretions. Chest radiograph interpretation should be performed by a blinded healthcare provider, preferably a radiologist or pulmonologist, not directly involved in assessment of the patient for enrollment or during subsequent care.
The letter also suggested that Uniform criteria should be applied to identify the quality of sputum and endotracheal aspirate specimens for culture and subsequent pathogen identification. The use of adjunctive antibacterial therapy should be minimized and rapid de-escalation criteria should be included in the study protocol.
For comments and feedback contact: editorial@rttnews.com
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.