Quantcast
Published On: Mon, Mar 31st, 2014

Sivextro, to treat MRSA skin infections, receives recommendation from FDA Anti-Infective Drugs Advisory Committee

PRESS RELEASE

Cubist Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) Anti-Infective Drugs Advisory Committee (AIDAC) voted to recommend approval of Cubist’s investigational antibiotic SIVEXTRO™ (tedizolid phosphate). In the unanimous 14 – 0 decision, the AIDAC found that substantial evidence of the safety and effectiveness of SIVEXTRO for the treatment of acute bacterial skin and skin structure infections (ABSSSI) was provided.

Credits:   CDC/Janice Carr

Credits: CDC/Janice Carr

SIVEXTRO is a once daily oxazolidinone being developed for both intravenous (I.V.) and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).  The Company’s New Drug Application (NDA) submission to the FDA for SIVEXTRO is based on positive data from two global Phase 3 clinical studies, which met the primary and secondary endpoints defined by the FDA and European Medicines Agency (EMA).

“We are very pleased with the strong endorsement from AIDAC members, and recommendation of approval for tedizolid, now known in the U.S. as SIVEXTRO.  We are encouraged by the recognition that there is a need for more treatment options for patients to address serious skin infections,” said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. “We look forward to the FDA’s final review of SIVEXTRO and decision.”

The AIDAC recommendation is not binding on the FDA, but will help inform the FDA as it completes its Priority Review of the NDA for SIVEXTRO, which has an assigned action date of June 20, 2014.  More information about the AIDAC meeting is available on the FDA website here.

Additionally, the EMA recently accepted for review the Company’s Marketing Authorization Application (MAA) for the investigational antibiotic, for which Cubist is seeking approval for the treatment of complicated skin and soft tissue infections (cSSTI). A decision from the European Commission (EC) is expected during the first half of 2015.

Tedizolid phosphate (formerly TR-701), now known in the U.S. as SIVEXTRO, is a novel oxazolidinone antibiotic drug candidate that is rapidly converted in vivo by phosphatases to the microbiologically active moiety TR-700. TR-700 acts by binding to the bacterial 50S ribosomal subunit thereby inhibiting protein synthesis. Tedizolid is being developed for both I.V. and oral administration in the potential treatment of ABSSSI, also referred to ascSSTI.  Tedizolid is also being investigated for potential use in nosocomial pneumonia (hospital-acquired bacterial pneumonia [HABP] and ventilator-associated bacterial pneumonia [VABP]).  Two Phase 3 studies, conducted in the U.S., Europe and other regions worldwide, in ABSSSI and cSSTI demonstrated that tedizolid 200 mg once daily for six days was statistically non-inferior to 10 days of linezolid 600 mg twice daily for the primary efficacy endpoints. Secondary endpoints were also met. In these studies, the adverse event rates were similar for both tedizolid and linezolid treated patients. Gastrointestinal adverse events (diarrhea, nausea and vomiting) were the most commonly reported in both treatment groups.

For more infectious disease news and information, visit and “like” the Infectious Disease News Facebook page and the Outbreak News This Week Radio Show page

unnamed

On the DISPATCH: Headlines  Local  Opinion

Subscribe to Weekly Newsletter

* indicates required
/ ( mm / dd ) [ALL INFO CONFIDENTIAL]

About the Author

- The generic Dispatch designation, used primarily for press releases or syndicated content, but may be used for guest author requesting a generic nomenclature

Displaying 17 Comments
Have Your Say
  1. Sivextro gets FDA approval, second MRSA antibiotic approved in a month | Outbreak News Today says:

    […] Three months ago, Cubist announced the U.S. Food and Drug Administration (FDA) Anti-Infective Drugs Advisory Committee (AIDAC) voted unanimously (14-0) for the approval of the then investigational oxazolidinone antibiotic. […]

  2. FDA panel endorses Cubist antibiotic – Boston Globe | HNP says:

    […] AfricaFDA Panel Gives Nod to New AntibioticsMedPage TodayReuters -Wall Street Journal -The Global Dispatchall 44 news […]

  3. FDA Panel Unanimously Oks Approval For Two Antibiotics, Dalvance And Sivextro – RTT News | Weight Loss Diet Plan says:

    […] The Global Dispatch […]

  4. FDA Panel Unanimously Oks Approval For Two Antibiotics, Dalvance And Sivextro – RTT News | Amazing News says:

    […] The Global Dispatch […]

  5. FDA panel endorses Cubist antibiotic – Boston Globe | Amazing News says:

    […] 3-US FDA panel votes in favor of two anti-infective drugsReutersWall Street Journal -The Global Dispatchall 45 news […]

  6. FDA panel endorses Cubist antibiotic – Boston Globe | Amazing News says:

    […] 3-US FDA panel votes in favor of two anti-infective drugsReutersWall Street Journal -The Global Dispatch -Chicago Tribune (blog)all 46 news […]

  7. FDA panel endorses Cubist antibiotic – Boston Globe | Amazing News says:

    […] 3-US FDA panel votes in favor of two anti-infective drugsReutersWall Street Journal -The Global Dispatch -Chicago Tribune (blog)all 44 news […]

  8. FDA panel endorses Cubist antibiotic – Boston Globe | Internet News 247 says:

    […] 3-US FDA panel votes in favor of two anti-infective drugsReutersWall Street Journal -The Global Dispatch -Chicago Tribune (blog)all 44 news […]

  9. FDA panel endorses Cubist antibiotic – Boston Globe | Amazing News says:

    […] 3-US FDA panel votes in favor of two anti-infective drugsReutersWall Street Journal -The Global Dispatch -Chicago Tribune (blog)all 43 news […]

  10. FDA panel endorses Cubist antibiotic – Boston Globe | Amazing News says:

    […] The Global Dispatch […]

  11. FDA Panel Gives Nod to New Antibiotics – MedPage Today | Amazing News says:

    […] Posttest. Two new antibiotics aimed at acute skin and skin structure infections each …Sivextro, to treat MRSA skin infections, receives recommendation from FDA Anti …The Global DispatchFDA Panel Recommends Two New AntibioticsWall Street JournalUPDATE 3-US FDA panel […]

  12. UPDATE 3-US FDA panel votes in favor of two anti-infective drugs – Reuters | Weight Loss Diet Plan says:

    […] Recommends Two New AntibioticsWall Street JournalFDA Panel Gives Nod to New AntibioticsMedPage TodaySivextro, to treat MRSA skin infections, receives recommendation from FDA Anti …The Global DispatchStreetInsider.com (subscription) -WTAQ -FierceBiotechall 30 news […]

  13. UPDATE 3-US FDA panel votes in favor of two anti-infective drugs – Reuters | RHN says:

    […] Gives Nod to New AntibioticsMedPage TodayFDA Panel Recommends Two New AntibioticsWall Street JournalSivextro, to treat MRSA skin infections, receives recommendation from FDA Anti …The Global DispatchReuters UK -StreetInsider.com (subscription) -KDALall 33 news […]

  14. UPDATE 3-US FDA panel votes in favor of two anti-infective drugs – Reuters | HNP says:

    […] = "000000"; ch_color_bg = "FFFFFF"; FDA Panel Recommends Two New AntibioticsWall Street JournalSivextro, to treat MRSA skin infections, receives recommendation from FDA Anti …The Global DispatchReuters UK -StreetInsider.com (subscription) -KDALall 33 news […]

  15. UPDATE 3-US FDA panel votes in favor of two anti-infective drugs – Reuters | Amazing News says:

    […] Gives Nod to New AntibioticsMedPage TodayFDA Panel Recommends Two New AntibioticsWall Street JournalSivextro, to treat MRSA skin infections, receives recommendation from FDA Anti …The Global DispatchReuters UK -StreetInsider.com (subscription) -WTAQall 32 news […]

  16. UPDATE 3-US FDA panel votes in favor of two anti-infective drugs – Reuters | HNW says:

    […] Two New AntibioticsWall Street Journal FDA Panel Gives Nod to New AntibioticsMedPage TodaySivextro, to treat MRSA skin infections, receives recommendation from FDA Anti …The Global DispatchStreetInsider.com (subscription) -WTAQ -Family Practice News Digital […]

  17. UPDATE 3-US FDA panel votes in favor of two anti-infective drugs – Reuters | Amazing News says:

    […] Recommends Two New AntibioticsWall Street JournalFDA Panel Gives Nod to New AntibioticsMedPage TodaySivextro, to treat MRSA skin infections, receives recommendation from FDA Anti …The Global DispatchStreetInsider.com (subscription) -WTAQ -FierceBiotechall 30 news […]

Leave a comment

XHTML: You can use these html tags: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>

like_us_on_facebook

 

The Global Dispatch Facebook page- click here

Movie News Facebook page - click here

Television News Facebook page - click here

Weird News Facebook page - click here 

DISPATCH RADIO

dispatch_radio

THE BRANDON JONES SHOW

brandon_jones_show-logo

Archives