WEP-CLINICAL
6.7.2020 13:02:10 CEST | Business Wire | Press release
WEP Clinical (WEP), a specialist pharmaceutical services company, has signed an exclusive agreement with Nabriva Therapeutics (Nabriva) to supply XENLETA® (lefamulin) on a named patient or expanded access basis. The Named Patient Program (NPP) is designed to ensure that physicians, contingent on meeting the necessary eligibility criteria and receiving approval, can request IV or oral XENLETA on behalf of patients who live in certain countries where it is not yet available.
XENLETA was discovered and developed by Nabriva (NASDAQ: NBRV), a commercial-stage biopharmaceutical company focused on commercialization and development of anti-infective agents. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. XENLETA is the first and only oral and IV pleuromutilin empiric antibiotic that acts against the pathogens that commonly cause CABP.
Nabriva announced on May 29th that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XENLETA for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed. The CHMP opinion will be reviewed by the European Commission (EC), which has the authority to approve medicines for all 28 countries of the European Union, Norway, Iceland, and Liechtenstein. A regulatory decision is anticipated during the second half of 2020.
Under the terms of the NPP, XENLETA will be made available in two formulations - 150mg injection for intravenous administration and 600mg oral tablets - using named patient or expanded access managed by WEP to enable healthcare professionals to access XENLETA for patients that have an unmet clinical need. Once a request is approved, WEP will manage the distribution of XENLETA to the treating physician and will provide any necessary follow-up support and services.
About WEP Clinical
Established in 2008, WEP Clinical is a specialist services company that works with drug developers to help patients and physicians gain early access to medicines when no other treatment options are available. We have offices located in the UK, US, Portugal and Ireland and possess all the necessary licenses allowing us to meet drug access and distribution needs across all regions, worldwide. We are passionate about helping those in need. For more information, please visit www.wepclinical.com .
About Nabriva Therapeutics
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 injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). XENLETA was discovered in Nabriva Therapeutics laboratories in Vienna, Austria. For more information, please visit www.nabriva.com .
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins.
XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.
WARNINGS AND PRECAUTIONS
XENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.
Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.
Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
ADVERSE REACTIONS
The most common adverse reactions (≥2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation.
USE IN SPECIFIC POPULATIONS
In patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations.
Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of XENLETA.
Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.
Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets.
XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose.
To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at 1-800-FDA-1088 or
https://www.fda.gov/safety/medwatch
View source version on businesswire.com: https://www.businesswire.com/news/home/20200706005015/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Andersen Consulting styrker sit cybersikkerhedstilbud gennem samarbejde med Trillium Information Security Systems21.3.2026 02:16:00 CET | Pressemeddelelse
Andersen Consulting udbygger sine kompetencer inden for teknologi og risikostyring gennem en samarbejdsaftale med Trillium Information Security Systems (TISS), et cybersikkerhedsfirma. Med en tilstedeværelse i Canada og Pakistan leverer TISS omfattende cybersikkerhedsløsninger til organisationer inden for finans, telekommunikation og den offentlige sektor. Virksomhedens team tilbyder et bredt udvalg af ydelser, herunder sikkerhedsvurderinger, managed security operations, red team-tjenester, digital efterforskning og hændelsesrespons samt GRC-rådgivning. Med næsten to årtiers erfaring leverer TISS adaptive, efterretningsdrevne forsvarsmekanismer, der hjælper kunder med at forudse og reagere på cybertrusler, der er i konstant udvikling. "Hos TISS arbejder vi på at skabe et mere sikkert digitalt miljø ved at give organisationer mulighed for at operere sikkert og med selvtillid," udtalte Mahir Mohsin Sheikh, administrerende direktør for TISS. "Vores samarbejde med Andersen Consulting giver
Andersen Consulting udvider sin teknologiplatform i Frankrig20.3.2026 17:28:00 CET | Pressemeddelelse
Andersen Consulting udvider sit udbud inden for digital transformation med en samarbejdsaftale med Teolia Consulting, et fransk firma, der specialiserer sig i projekt- og produktstyring, cloud-platformsudvikling, datatransformation samt implementering og brug af Atlassian-pakken. Teolia Consulting blev grundlagt i 2014 og hjælper organisationer med at opnå digital performance, fra agile metoder til løsninger, der reducerer lanceringstiden. Virksomhedens ekspertise består i at levere integrerede strategier, der bringer teknologi og organisatorisk forandring i overensstemmelse. Virksomheden arbejder på tværs af brancher, herunder inden for bank- og finanssektoren, forsikring, mode og detailhandel, og hjælper kunder med at få større robusthed og accelerere deres digitale modenhed. "Hos Teolia Consulting mener vi, at ægte transformation opstår, når teknologi og mennesker udvikler sig sammen," sagde Lucienne Jacquet, der er administrerende partner i Teolia. "Ved at samarbejde med Andersen C
Incyte to Highlight Late-Breaking Hidradenitis Suppurativa Data at the 2026 American Academy of Dermatology (AAD) Annual Meeting20.3.2026 15:00:00 CET | Press release
- New, late-breaking 54-week data for povorcitinib in hidradenitis suppurativa (STOP-HS1 & STOP-HS2) to be highlighted - Featured abstracts for ruxolitinib cream (Opzelura®) and povorcitinib include multiple ePosters in atopic dermatitis, hidradenitis suppurativa and vitiligo Incyte (Nasdaq:INCY) today announced that data from key programs in its Inflammation and Autoimmunity (IAI) franchise will be presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting, to be held March 27 – 31, 2026, in Denver. “At AAD 2026, we are presenting late‑breaking 54-week results from the Phase 3 STOP‑HS program evaluating povorcitinib in hidradenitis suppurativa (HS),” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation and Autoimmunity, Incyte. “These data provide longer term evidence of the safety and efficacy of povorcitinib in HS patients and further strengthen the significant growth potential of our Inflammation and Autoimmunity franchise.” Details on key data presentation
MUSASHI JAPAN by TAIMATSU Launches “Road to Shogun” – A Journey Through Craftsmanship and Discovery20.3.2026 13:58:00 CET | Press release
Musashi Japan by TAIMATSU Co., Ltd., a contemporary Japanese knife brand rooted in the spirit of craftsmanship and cultural harmony, has announced its newest experiential campaign: “Road to Shogun.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260320887471/en/ Designed as the brand’s most ambitious customer journey to date, the campaign invites visitors to explore participating Musashi Japan stores while discovering the traditions, culture and craftsmanship that inspire the brand. Inspired by the journey towards mastery, the experience encourages participants to progress through a series of ranks whilst visiting stores and unlocking rewards that celebrate elements of everyday Japanese culture. At Musashi Japan, craftsmanship is not only about the final product, but also about the path taken to achieve mastery. The Road to Shogun reflects this philosophy by guiding customers through a journey that mirrors the dedication, cu
Futur Delivers Strong Growth and Record Profit in 202520.3.2026 12:05:00 CET | Press release
In 2025, Futur added 21,000 new customers and the inflows amounted to 34 billion kronor. At the end of the year, the total savings capital was 252 billion kronor, an increase of 7% from the previous year and a new record level. "2025 was a record year for Futur. In a market characterized by sharp market fluctuations, Futur continued to invest, grow and deliver strong results. Behind this record performance is stable customer growth, strong inflows and cost discipline. Our close cooperation with over 60 partners gives customers the freedom to choose the asset management and advisory services that best suit them. The strategy of letting the customer choose is appreciated, which is reflected in us welcoming more than 21,000 new customers during the year", says Torgny Johansson, CEO of Futur. "We are optimistic about the future. Futur has great opportunities to continue growing in the coming years by developing innovative and efficient services for savings and pensions. I am proud of how a
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom