Two companies, Theravance and Targanta, have developed two new glycopeptide antibiotics, similar to vancomycin that the US Food and Drug Administration (FDA) will consider for approval. This is very welcome news because antibiotic treatment options continue to diminish as bacterial antibiotic resistance continues to skyrocket. Unfortunately, like vancomycin, both antibiotics must be administered intravenously to treat infections.
Theravance filed a new drug application(NDA) with FDA for telavancin, a bactericidal, once-daily injectable antibiotic proposed to treat complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The company received an approvable letter from FDA for telavancin but was asked for additional information to determine whether the agency will approve the drug. Theravance received notice in December from FDA that the agency's Anti-Infective Drugs Advisory Committee will meet on February 27 to review the new information and make a recommendation on telavancin’s approvability.
Targanta expects to file a NDA for its antibiotic, oritivancin, in the first quarter of 2008. Oritavancin is a semi-synthetic glycopeptide antibiotic with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria. Two Phase 3 studies for the treatment of complicated skin and skin structure infection (cSSSI) have been completed. The antibiotic was originally discovered in the mid 90s by Eli Lilly research laboratories. In 2001, Lilly licensed oritivancin to Intermune who subsequently finished the phase III studies, but delayed filing the NDA in 2004 because of adverse side effects including injection site phlebitis. In 2005, Intermune divested itself of oritavancin and sold the worldwide ownership rights to Targanta.
The company apparently delayed submitting its NDA for oritivancin to FDA (even though the data were available for a couple of years) because the agency has been described as fickle when it comes to antibiotic approvals. Apparently, Targanta executives wanted to see how telavancin fared with FDA before it filed its application. Nevertheless, approval of the ortivancin NDA is strongly contingent upon information describing the benefits of oritavancin over vancomycin.
While neither antibiotic is groundbreaking for the treatment of infections caused by Gram positive pathogens, they both offer certain benefits over vancomycin. Further, the addition of these new antibiotics to our current antibacterial armamentarium is timely given the growing incidence of vancomycin-resistant bacterial isolates.
Cambridge, Mass-based Targanta Therapeutics announced Monday that it had finally submitted a new drug application to the U.S. Food and Drug Administration for its lead product, the antibiotic oritavancin. As mentioned in a previous post Targanta executives had decided to delay the submission of the oritavancin NDA.
