FDA News

FDA Advisory committee deems tedizolid effective, safe for ABSSSI

The FDA’s Anti-Infective Drugs Advisory Committee voted unanimously that there is substantial evidence that tedizolid is safe and effective for the treatment of acute bacterial skin and skin structure infections caused by several organisms, including MRSA.

“The biological plausibility of a 6-day, short-course therapy should be applauded,” committee member Paul G. Auwaerter, MD, of John Hopkins University School of Medicine, told the panel. “It looks like this will be an effective treatment option.”

Regarding safety concerns, Auwaerter said that it should be clear that the limited adverse effect profile seen with the drug is related to a 6-day course of therapy. Adverse effects seen with similar drugs, like linezolid, appear to be dose- and duration-related. More studies are needed to observe the adverse effects of the drug when given for longer courses.

The effectiveness of tedizolid (Cubist) was evaluated in two phase-3 trials in which patients were randomly assigned tedizolid once-daily for 6 days or linezolid twice-daily for 10 days. Both studies demonstrated that tedizolid was non-inferior to linezolid (Zyvox, Pfizer) against ABSSSI caused by susceptible isolates, including Staphylococcus aureus, both methicillin-resistant and methicillin-sensitive.

“When I see a noninferiority trial, I want to see some benefit, and the only real benefit I see is that it’s a once-daily dosing for a shorter period of time,” committee member Michael Neely, MD, of the University of Southern California, told the panel. “The toxicity seems to be equivalent to linezolid, but we certainly need more postmarketing data on long-term safety.

Michael Neely, MD, MSc 

Michael Neely

Neely, a pediatric infectious disease specialist, did say he thinks the drug should not be approved for adolescents aged 12 to 18 years due to the limited data for this group. He also said that the label should indicate that efficacy has not been established for the immunocompromised and warn of cross-resistance with linezolid-resistant isolates.

The FDA’s Anti-Infective Drugs Advisory Committee voted unanimously that there is substantial evidence that tedizolid is safe and effective for the treatment of acute bacterial skin and skin structure infections caused by several organisms, including MRSA.

“The biological plausibility of a 6-day, short-course therapy should be applauded,” committee member Paul G. Auwaerter, MD, of John Hopkins University School of Medicine, told the panel. “It looks like this will be an effective treatment option.”

Regarding safety concerns, Auwaerter said that it should be clear that the limited adverse effect profile seen with the drug is related to a 6-day course of therapy. Adverse effects seen with similar drugs, like linezolid, appear to be dose- and duration-related. More studies are needed to observe the adverse effects of the drug when given for longer courses.

The effectiveness of tedizolid (Cubist) was evaluated in two phase-3 trials in which patients were randomly assigned tedizolid once-daily for 6 days or linezolid twice-daily for 10 days. Both studies demonstrated that tedizolid was non-inferior to linezolid (Zyvox, Pfizer) against ABSSSI caused by susceptible isolates, including Staphylococcus aureus, both methicillin-resistant and methicillin-sensitive.

“When I see a noninferiority trial, I want to see some benefit, and the only real benefit I see is that it’s a once-daily dosing for a shorter period of time,” committee member Michael Neely, MD, of the University of Southern California, told the panel. “The toxicity seems to be equivalent to linezolid, but we certainly need more postmarketing data on long-term safety.

Michael Neely, MD, MSc 

Michael Neely

Neely, a pediatric infectious disease specialist, did say he thinks the drug should not be approved for adolescents aged 12 to 18 years due to the limited data for this group. He also said that the label should indicate that efficacy has not been established for the immunocompromised and warn of cross-resistance with linezolid-resistant isolates.