FDA Accepts For Review Theravance's Complete Response Submission For Telavancin For The Treatment Of Complicated Skin And Skin Structure Infections

Main Category: Dermatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 28 Apr 2009 - 0:00 PDT

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Theravance, Inc. (NASDAQ: THRX) announced that the U.S. Food and Drug Administration (FDA) accepted as complete for review Theravance's response to the February 2009 Complete Response letter, which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a novel, bactericidal, once-daily injectable investigational antibiotic studied in the treatment of cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 16, 2009.

"We look forward to further advancing our application through the FDA's review process," said Rick E Winningham, Chief Executive Officer. "We will continue to work with the FDA in finalizing the telavancin label, in order to bring the benefits of telavancin to patients with complicated skin and skin structure infections."

About Telavancin

Telavancin is a bactericidal, once-daily injectable investigational antibiotic with a multifunctional mechanism of action. Telavancin was discovered by Theravance in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus, including MRSA, and other Gram-positive bacteria. Telavancin inhibits the formation of the bacterial cell wall and disrupts bacterial cell membrane function. Theravance believes the additive mechanisms of action seen with telavancin speed bacterial killing while also reducing the risks of inducing resistance to telavancin or cross-resistance with other antibiotics. Telavancin has been studied in two Phase 3 programs, one in cSSSI and one in HAP, both of which demonstrated non-inferiority in the all-treated (AT) and clinically evaluable (CE) patient populations versus vancomycin. Theravance believes these clinical programs comprise the largest global studies ever conducted in patients with confirmed MRSA infections. In addition to the cSSSI NDA, the FDA is currently reviewing Theravance's NDA for the treatment of nosocomial pneumonia (also known as hospital-acquired pneumonia, or HAP).

Source
Theravance

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