Navigation Links
The European Commission Grants Marketing Authorization for DIFICLIR™ (fidaxomicin) Tablets for Treatment of Clostridium difficile Infections
Date:12/12/2011

SAN DIEGO, Dec. 12, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) and Astellas Pharma Europe Ltd., a European subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503) announced today that the European Commission has granted Marketing Authorization (MA) for DIFICLIR™ (fidaxomicin) tablets for the treatment of adults with Clostridium difficile infections (CDI) also known as Clostridium difficile-associated diarrhea (CDAD). CDI is a significant problem in hospitals and long-term care facilities all over the world. EMA approval was based on two large, multi-national, Phase 3 clinical trials that demonstrated that DIFICLIR was as effective as oral vancomycin in treating CDI. DIFICLIR had a significantly lower rate of recurrence (including relapses) compared to vancomycin in the 30 days following treatment.  DIFICLIR is the only drug approved by the EMA proven to significantly lower the rate of recurrence of CDI compared to oral vancomycin. The clinical trials included patients over the age of 65 and those taking concomitant antibiotics to treat multiple infections.

"The European approval is a key step in making fidaxomicin more widely available to patients across the globe to treat this very serious disease," said Pedro Lichtinger, President and Chief Executive Officer of Optimer. "We believe we have obtained a very strong label recognizing the benefits of DIFICLIR versus vancomycin, including significant reductions in recurrence."

The European approval affirms the recent positive opinion from the Committee of Medicinal Products for Human Use (CHMP) and is based on two Phase 3 clinical trials that were conducted to ensure the safety and efficacy of 400mg/day DIFICLIR (fidaxomicin) tablets compared to 500mg/day oral vancomycin for 10 days in subjects with CDI. The first Phase 3 study was carried out in 629 subjects in No
'/>"/>

SOURCE Optimer Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. ULURU Inc. Extends the European Altrazeal® License to Include Australia and New Zealand
2. Ampio Pharmaceuticals Awarded European Patent that Strengthens Intellectual Property Protection for its key drug Ampion™
3. Avanafil Data Presented at the European Society of Sexual Medicine Meeting
4. European Medicines Agencys (EMA) Committee for Human Medicinal Products (CHMP)Tentatively Scheduled to Render an Opinion on PixuvriTM Marketing Authorization Application on January 19, 2012
5. CardioInsight Announces CE Mark Clearance and European Launch of the ECVUE™ Non-Invasive Electrocardiographic Mapping System
6. Omeros Announces Submission to European Medicines Agency of Paediatric Investigation Plan Letter of Intent for OMS302
7. Delcath Announces Agreement With European Institute of Oncology for Initial Launch of Hepatic Chemosat Delivery System in the European Union
8. X-ray Equipment - Top 5 European Markets
9. Amsterdam Molecular Therapeutics Receives Orphan Designation in the European Union for Hemophilia B Gene Therapy
10. RSB Spine, LLC, Announces European Patent Allowance
11. Vectibix® (Panitumumab) Granted Approval for Expanded Indications in the European Union
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/17/2014)... 2014 ... has announced the addition of the  ... Automated External Defibrillators (AED) Market"  report ... ,The report North American Automated External ... of devices based upon following sub-segments ...
(Date:10/17/2014)... Oct. 17, 2014  Talyst, a market leader in ... Annual Meeting in Nashville, TN. ... market leading solution for onsite, remote medication dispensing. ... facilities to safely and securely dispense medication onsite, on ... dose, helps ensure that the correct medication gets to ...
(Date:10/17/2014)... -- China Biologic Products, Inc. (NASDAQ: CBPO, "China Biologic" ... biopharmaceutical company in China , ... from the China Food and Drug Administration (the ... concentrate ("PCC") at its Shandong Taibang facility. The ... facility for Good Manufacturing Practices ("GMP") compliance in ...
Breaking Medicine Technology:Micro Market Monitor : North American Automated External Defibrillators (AED) Market 2Talyst Exhibits at LeadingAge Annual Meeting 2China Biologic Receives Approval for Commercial Manufacturing of Human Prothrombin Complex Concentrate at Shandong Taibang Facility 2China Biologic Receives Approval for Commercial Manufacturing of Human Prothrombin Complex Concentrate at Shandong Taibang Facility 3
... 14, 2011 Micross Components, a leading global ... as General Manager of its US Products & ... product and business development, will play a leading ... its offerings to increase market share across several ...
... YORK and JERUSALEM, Sept. 14, 2011 Chiasma, Inc., a ... & CEO, will present an overview of the Company at ... New York, New York, on Monday, September 19, 2011 at ... an oral form of octreotide acetate being developed first for ...
Cached Medicine Technology:Micross Components Names Mike Deley as General Manager of US Products & Services Division 2Chiasma to Present at the UBS Global Life Sciences Conference 2
(Date:10/20/2014)... October 20, 2014 The Advocator ... booth at the American Foundation for Suicide Prevention’s (AFSP) ... AFSP is a not-for-profit organization that hosts hundreds of ... from these events are used to help understand and ... and personal relationships as well. , The Advocator ...
(Date:10/20/2014)... Zereana Jess-Huff, a 34-year-old mother, corporate executive and ... platform to think outside the bra. She doesn’t try to ... raise awareness about women’s other lady parts. , "We have ... the color pink and everybody knows what you’re talking about,” ... it has not been won when it comes to gynecologic ...
(Date:10/20/2014)... (PRWEB) October 20, 2014 ... Voicheck as Assistant Director of their CentralSource ... in managing the innovative turnkey drug sourcing, distribution, ... Matthew brings over 12 years of industry experience, ... Myoderm at the peak of their international success ...
(Date:10/20/2014)... (PRWEB) October 20, 2014 Final Cut Pro ... release of the Citrus theme for FCPX filmmakers . ... use to describe the Citrus theme” Says Christina Austin, CEO ... to look so professional.” , Citrus comes with all the ... the template are: four transitions for added style, a title ...
(Date:10/20/2014)... 2014 Do you ever feel difficulty ... a wonderful app Metassessor for teachers, specialists and parents. ... helped its client “Intervention Development LLC” to launch Metassessor ... designed for iOS 4.3 or later and is Compatible ... optimized for iPhone 5. It is now available on ...
Breaking Medicine News(10 mins):Health News:The Advocator Group, LLC is Proud to Participate in an Out of the Darkness Community Walk, October 25th, to Increase Suicide Awareness 2Health News:The Advocator Group, LLC is Proud to Participate in an Out of the Darkness Community Walk, October 25th, to Increase Suicide Awareness 3Health News:Ovarian Cancer Survivor Mrs. Maryland Urges Media to Think Outside the Bra 2Health News:Ovarian Cancer Survivor Mrs. Maryland Urges Media to Think Outside the Bra 3Health News:Myoderm Hires Matthew Voicheck to Lead Turnkey Drug Sourcing Service 2Health News:Today Pixel Film Studios Announced the Release of the Citrus theme for Final Cut Pro X 2Health News:Metassessor App Launched: an RTI tool for Teachers & Parents 2Health News:Metassessor App Launched: an RTI tool for Teachers & Parents 3
... campaign targets push towards cultural changes that promote ... a leading developer of technology for the safe ... the launch of a targeted campaign recognizing patient ... is intended to emphasize the need for a ...
... VIEW, Calif., March 10 IRIDEX Corporation (Nasdaq: ... quarter and full fiscal year ended January 3, 2009.Revenues for ... decrease from the $14.1 million reported for the fourth quarter ... or $0.74 per diluted share for the fourth quarter of ...
... in America, and many old people themselves trade in unflattering ... are not only false and cruel, they are also unhealthy. ... age stereotypes tend to fulfill them. , And it may ... A new study in Psychological Science , a journal ...
... host seminar Tuesday, March 17, 2009, from 8:30 to 9:30 ... the leading expert in ion channels and GPCRs (G-protein coupled ... will feature the latest in its expanding line of services ... conference March 15-19, in Baltimore, Maryland. ChanTest,s growing catalog, comprising ...
... to Mount For Strawberry Nutrition BenefitsWATSONVILLE, Calif., March 10 ... of super foods that improve health and ... on time. A new study published in the scientific ... in strawberries help lower "bad" cholesterol.The study, conducted by ...
... March 10 Stamford-based Olympus Partners is pleased ... Corp. from The Hansen Corporate Group. Holopack ... its name to The Ritedose Corporation (TRC).TRC is ... United States. In the BFS process, a ...
Cached Medicine News:Health News:Baxa Corporation Launches 'Culture of Safety' Campaign to Recognize National Patient Safety Awareness Week 2Health News:Baxa Corporation Launches 'Culture of Safety' Campaign to Recognize National Patient Safety Awareness Week 3Health News:IRIDEX Reports Fourth Quarter and Full Year 2008 Financial Results 2Health News:IRIDEX Reports Fourth Quarter and Full Year 2008 Financial Results 3Health News:IRIDEX Reports Fourth Quarter and Full Year 2008 Financial Results 4Health News:IRIDEX Reports Fourth Quarter and Full Year 2008 Financial Results 5Health News:IRIDEX Reports Fourth Quarter and Full Year 2008 Financial Results 6Health News:IRIDEX Reports Fourth Quarter and Full Year 2008 Financial Results 7Health News:IRIDEX Reports Fourth Quarter and Full Year 2008 Financial Results 8Health News:The perils of ageism 2Health News:ChanTest to Highlight Expanded Ion Channel and GPCR Services and Cell Lines, Including FDA Critical Path Safety Profiling Tools at ToxExpo, Booth 3056 2Health News:ChanTest to Highlight Expanded Ion Channel and GPCR Services and Cell Lines, Including FDA Critical Path Safety Profiling Tools at ToxExpo, Booth 3056 3Health News:Spoonfuls of Strawberries Help the Cholesterol Go Down 2Health News:Spoonfuls of Strawberries Help the Cholesterol Go Down 3
... brightest and most versatile light source Luxtec ... Watts, this unique light source allows to ... illuminated instrument or two UltraLite Headlights at ... bright, white light that is as close ...
Loupe KS is achieved by a special system carrier....
... magnification for advanced surgical procedures. Prismatic quality ... the highest magnification. 3.5x, 4.5x and 5.5x. ... rendition is ideal for surgical applications. Precision ... a superior image. The compact abd lightweight ...
... magnification for advanced surgical procedures. Prismatic quality ... the highest magnification. 3.5x, 4.5x and 5.5x. ... rendition is ideal for surgical applications. Precision ... a superior image. The compact abd lightweight ...
Medicine Products: