Retapamulin

Nabriva Publishes Clinical Data Analysis Highlighting Benefits of Outpatient Management of Community Acquired Bacterial Pneumonia (CABP) with Oral XENLETA® (lefamulin)

Retrieved on: 
Tuesday, March 16, 2021
Chemical compounds, Organic compounds, Chemistry, Lefamulin, Antibiotic, Retapamulin, Pleuromutilin

XENLETA is the first IV and oral antibiotic with a novel mechanism of action approved by the FDA in nearly two decades.

Key Points: 
  • XENLETA is the first IV and oral antibiotic with a novel mechanism of action approved by the FDA in nearly two decades.
  • Demographics and baseline clinical characteristics were generally similar between treatment groups and were broadly reflective of the patient population with CABP.
  • XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for administration in humans discovered and developed by the Nabriva Therapeutics team.
  • Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin), the first pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).

Nabriva Therapeutics and Sinovant Sciences Restructure License Agreement for XENLETA for Community-Acquired Bacterial Pneumonia in China

Retrieved on: 
Monday, December 7, 2020
Chemical compounds, Organic compounds, Chemistry, Antibiotic, Lefamulin, Pleuromutilin, Retapamulin, Pneumonia

In March 2018, Nabriva granted to Sinovant Sciences an exclusive license to develop and commercialize XENLETA (SNV001) in China.

Key Points: 
  • In March 2018, Nabriva granted to Sinovant Sciences an exclusive license to develop and commercialize XENLETA (SNV001) in China.
  • In addition, Nabriva will be eligible to receive low double-digit royalties on sales of XENLETA following regulatory approval in the greater China region.
  • XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for administration in humans discovered and developed by the Nabriva Therapeutics team.
  • Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin), the first pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).

NABRIVA Receives European Approval for XENLETA® (lefamulin) for Treatment of Community-Acquired Pneumonia (CAP)

Retrieved on: 
Tuesday, July 28, 2020
Organic compounds, Chemical compounds, Chemistry, Antibiotic, Lefamulin, Retapamulin, Pleuromutilin, RTT

The U.S. Food and Drug Administration (FDA) approved XENLETA for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) in August 2019.

Key Points: 
  • The U.S. Food and Drug Administration (FDA) approved XENLETA for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) in August 2019.
  • The EMA approval is based on efficacy data from the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 studies and a safety database of 1,242 study participants.
  • Food and Drug Administrationapproval for XENLETA (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).
  • XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team.

XENLETA® (lefamulin) Receives Health Canada Approval for Treatment of Community Acquired Pneumonia

Retrieved on: 
Thursday, July 16, 2020
Chemistry, Organic compounds, Chemical compounds, Thioethers, Antibiotic, Lefamulin, Retapamulin, Pleuromutilin, Sunovion, Medication

Additional information on the Notice of Compliance from Health Canada dated July 10, 2020 is available at https://health-products.canada.ca/noc-ac/info.do?lang=en&no=23888 .

Key Points: 
  • Additional information on the Notice of Compliance from Health Canada dated July 10, 2020 is available at https://health-products.canada.ca/noc-ac/info.do?lang=en&no=23888 .
  • Nabriva entered into a license and commercialization agreement in March 2019 with Sunovion Pharmaceuticals Canada Inc. for XENLETA in Canada.
  • Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).
  • XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team.

Nabriva Therapeutics Receives Positive EU CHMP Opinion for XENLETA™ (lefamulin) for the Treatment of Community-Acquired Pneumonia (CAP)

Retrieved on: 
Friday, May 29, 2020
Organic compounds, Chemistry, Health sciences, Antibiotic, Lefamulin, Retapamulin, Therapy

XENLETA has a novel mechanism of action and provides an urgently needed short course, empiric monotherapy treatment alternative for adult patients with CAP.

Key Points: 
  • XENLETA has a novel mechanism of action and provides an urgently needed short course, empiric monotherapy treatment alternative for adult patients with CAP.
  • The U.S. Food and Drug Administration (FDA) approved XENLETA in August 2019 for the treatment of adult patients with community-acquired bacterial pneumonia (CABP).
  • Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).
  • XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team.

Centers for Medicare & Medicaid Services Issues Product-Specific J-Code for XENLETA

Retrieved on: 
Thursday, April 9, 2020
Organic compounds, Chemical compounds, Chemistry, Thioethers, Antibiotic, Lefamulin, Retapamulin, Pleuromutilin

Having a unique J-code for XENLETA will help facilitate more efficient billing for hospitals and will assist in the tracking of XENLETA in claims data.

Key Points: 
  • Having a unique J-code for XENLETA will help facilitate more efficient billing for hospitals and will assist in the tracking of XENLETA in claims data.
  • Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).
  • XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team.
  • Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP.

Nabriva Therapeutics to Report 2019 Financial Results and Recent Corporate Highlights on March 12, 2020

Retrieved on: 
Tuesday, March 10, 2020
Organic compounds, Chemistry, Chemical elements, Thioethers, Antibiotic, Retapamulin

ET to discuss the financial results and recent corporate highlights.

Key Points: 
  • ET to discuss the financial results and recent corporate highlights.
  • Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections.
  • Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).
  • These forward-looking statements should not be relied upon as representing Nabriva Therapeutics views as of any date subsequent to the date of this press release.

Nabriva Therapeutics to Present at the 31st Annual Piper Jaffray Healthcare Conference

Retrieved on: 
Thursday, November 21, 2019
Organic compounds, Chemistry, Antibiotic, Drugs, Lefamulin, Retapamulin

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections.

Key Points: 
  • Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections.
  • Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).
  • In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics views as of the date of this press release.
  • These forward-looking statements should not be relied upon as representing Nabriva Therapeutics views as of any date subsequent to the date of this press release.

Nabriva to Present Data from XENLETA (lefamulin) and CONTEPO (fosfomycin) Development Programs at IDWeek 2019

Retrieved on: 
Thursday, September 26, 2019
Organic compounds, Chemistry, Drugs, Antibiotic, Retapamulin, Pneumonia, Lefamulin, Omadacycline

Lefamulin data being presented has been generated from the companys community-acquired bacterial pneumonia (CABP) clinical trial and in vitro surveillance programs.

Key Points: 
  • Lefamulin data being presented has been generated from the companys community-acquired bacterial pneumonia (CABP) clinical trial and in vitro surveillance programs.
  • Nabriva plans to resubmit the new drug application (NDA) for CONTEPO early in the fourth quarter of 2019.
  • We are excited to share our latest clinical data on the safety and efficacy of XENLETA and CONTEPO with the infectious disease community at IDWeek, said Jennifer Schranz MD, Chief Medical Officer of Nabriva Therapeutics.
  • Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).

Nabriva Therapeutics to Present at the 2019 Cantor Global Healthcare Conference

Retrieved on: 
Wednesday, September 18, 2019
Organic compounds, Chemistry, Antibiotic, Lefamulin, Retapamulin

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections.

Key Points: 
  • Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections.
  • Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).
  • In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics views as of the date of this press release.
  • These forward-looking statements should not be relied upon as representing Nabriva Therapeutics views as of any date subsequent to the date of this press release.