Posted on February 25, 2008 by BioJobBlogger

FDA Delays Decisions on Two New Antibiotics to Treat MRSA

The US Food and Drug Administration said Monday it still had several "outstanding issues" with televancin an antibiotic being developed by Theravance Inc and Astellas Pharma of Tokyo. to treat skin infections.

The agency had canceled an advisory committee meeting scheduled for Wednesday that was set to evaluate the drug, televancin.

In a statement, the agency said that the meeting was being canceled to "allow time for the FDA to review and resolve several outstanding issues." The FDA said it would schedule an advisory committee meeting in the future, if needed.

Televancin is a once-daily injectable antibiotic that would be used to treat skin infections, including those caused by resistant bacteria like methicillin-resistant Staphylococcus aureus (MRSA). In October the FDA issued a so-called approvable letter for televancin, suggesting it needed a re-analysis of clinical data and the resolution of manufacturing issues at a third-party manufacturer that was not specifically related to televancin. The FDA said it continues to review televancin's application but didn't give a timetable for completion of the review.

Earlier this month the FDA canceled a Feb. 28 meeting for another antibiotic, ceftobiprole that would also be used to treat skin infections. That drug is being developed by a unit of Johnson and Johnson Co. and Switzerland-based Basilea Pharmaceutica Ltd. The FDA is expected to make a decision on whether to approve ceftobriprole sometime next month.

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Posted on February 11, 2008 by BioJobBlogger

Targanta Finally Files New Antibiotic NDA

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.

Oritavancin is being touted as a viable option for treating antibiotic-resistant bacterial infections. It would compete in the marketplace against drugs including telavancin being developed by Theravance and cubicin, an antibiotic offered by Cubist Pharmaceuticals Inc to treat skin and blood infections.

Targanta has backed up its application with data from 19 clinical trials including two late-stage human clinical trials. More than 2,100 patients took part in the clinical testing of the drug.

I wish Targanta luck–we need new antibiotics!

Until next time…

Good Luck and Good Job Hunting

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Posted on February 2, 2008 by BioJobBlogger

Two New Antibiotics on the Horizon

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.

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