Navigation Links
Optimer Pharmaceuticals and Astellas Receive Positive Opinion from CHMP for European Approval of DIFICID™
Date:9/23/2011

SAN DIEGO, Sept. 23, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for DIFICLIR™ (fidaxomicin) tablets for the treatment of adults suffering with a Clostridium difficile infection (CDI), also known as C. difficile-associated diarrhea (CDAD).

(Logo: http://photos.prnewswire.com/prnh/20090413/LA97352LOGO)

DIFICLIR, which is known as DIFICID™ in the United States (US), was approved by the US FDA in May 2011 for the treatment of CDAD in adults 18 years of age and older. Astellas is Optimer's exclusive licensee to develop and commercialize DIFICLIR in Europe and certain other countries in the Middle East, Africa and the Commonwealth of Independent States.

The CHMP positive opinion is based on Phase 3 clinical studies that were conducted to compare the safety and efficacy of 400mg/day fidaxomicin with 500mg/day oral vancomycin for 10 days in subjects with CDI. The first Phase 3 study was carried out in 629 subjects in North America (US and Canada). The second Phase 3 study was carried out in 535 subjects in North America and Europe. The results of the studies showed that the proportion of subjects in which clinical cure was achieved at the end of 10 days of treatment were similar for both treatments; thus fidaxomicin met its primary endpoint of non-inferiority to vancomycin. Furthermore in both trials, fidaxomicin had a significantly lower rate of recurrence of CDI compared to vancomycin at 30 days after completion of treatment.

"A positive CHMP opinion is an important milestone for Optimer and is a key step to making fidaxomicin more widely available to patients around the globe for this serious dis
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Optimer to Provide DIFICID™ Launch Update at Morgan Stanley Global Healthcare Conference
2. Optimer Pharmaceuticals DIFICID Featured in 11 Presentations at 51st ICAAC
3. Optimer Pharmaceuticals to Present at September 2011 Investor Conferences
4. Optimer Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
5. Clinical Infectious Diseases Publishes Subgroup Analysis Showing Optimers DIFICID™ (fidaxomicin) Tablets Exhibited Higher Clinical Cure and Global Cure Rates Than Vancomycin in Patients with Clostridium difficile-Associated Diarrhea (CDAD) Receivin
6. Optimer Pharmaceuticals Reports Second Quarter 2011 Financial Results
7. Optimer Launches DIFICID™ (fidaxomicin) Tablets for Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) in Patients 18 Years of Age and Older
8. Optimer Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
9. Optimer Pharmaceuticals to Present at the Jefferies 2011 Global Healthcare Conference
10. Optimer Pharmaceuticals Reports First Quarter 2011 Financial Results
11. Optimer Pharmaceuticals Expands Senior Management Team
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , Jan. 15, 2014  A novel wearable injector slightly larger ... painless for patients to self-inject prescription drugs in the large ... cancer, blood diseases, autoimmune deficiencies, and genetic disorders.  ... to $220B by 2018, according to analysts.   Many of these ...
(Date:1/14/2014)... HILLS, Calif. , Jan. 14, 2014 The Brandeis Medical ... Los Angeles a premier and affordable laser tattoo removal ... special. Dr. Brandeis, focus is in providing high quality cosmetic services ... all patients. " Southern California has ...
(Date:1/14/2014)... 14, 2014   NuAire , a manufacturer of ergonomically designed ... Hitachi Koki of Japan to sell ... America . NuAire will utilize its network of sales professionals ... Canada to offer assistance in application use, product benefits ...
Breaking Medicine Technology:Enable Injections Presents A New Class of Injectors for Drug Delivery at PEPTalk, Drug Delivery Partnership Meetings 2Beverly Hills Physician Features Tattoo Removal with the Astanza Duality Laser, Offers $99 Special 2NuAire announces sales and service of Hitachi Koki centrifuges in North America 2
... N.C., Oct. 31 AlphaVax, Inc.,announced today that it ... of an influenza vaccine based on its proprietary replicon ... properties of this,unique vector system as well as the ... was a placebo-controlled, randomized, double-blind trial in,healthy adults, 18-40 ...
... guide low-income,and minority cancer patients through cancer treatment, ... major obstacles that prevent them,from receiving quality care ... October 28, 2007, at the American Society for ... Angeles. Minority and low-income cancer patients continue ...
Cached Medicine Technology:AlphaVax Announces Results From Phase 1 Influenza Vaccine Clinical Trial 2Patient Navigators Help Minority, Low-Income Cancer Patients Get Life-Saving Treatments 2
(Date:7/9/2014)... risen dramatically in Western societies. One frequently cited reason ... have fewer infections than previous generations, thereby delaying maturation ... at Sahlgrenska Academy, University of Gothenburg, monitored children until ... immune system in relation to allergic disease. All of ... Gtaland Region, half of them on farms that produced ...
(Date:7/8/2014)... kidney donors enjoy similar longevity and cardiovascular health as ... published in the American Journal of Transplantation . ... considering donation and the transplant professionals caring for them. ... by individuals aged 55 years and older has become ... disease, and heart disease, the removal of a kidney ...
(Date:7/8/2014)... Defense Advanced Research Projects Agency (DARPA) awarded Lawrence ... to develop an implantable neural device with the ... brain to help restore memory, DARPA officials announced ... understanding that memory is a process in which ... information, store it and retrieve it. Certain types ...
(Date:7/8/2014)... found to be three times higher when auditors were ... auditors present, according to a study in a major ... "Quantification of the Hawthorne effect in hand hygiene compliance ... study," published today on-line in the BMJ Quality ... Srigley, who did the study as part of her ...
(Date:7/8/2014)... discovered a biomarker that could give expecting mothers and ... predict that a pregnant woman may develop preeclampsia, at ... , Preeclampsia is a cardiovascular disorder generally occurring late ... creating immediate and potentially lifelong risks to both mother ... in the urine, and is typically diagnosed in the ...
Breaking Medicine News(10 mins):Health News:Study finds kidney donation safe for healthy older adults 2Health News:DARPA selects Lawrence Livermore to develop world's first neural device to restore memory 2Health News:DARPA selects Lawrence Livermore to develop world's first neural device to restore memory 3Health News:Health-care worker hand hygiene rates increase three-fold when auditors visible 2Health News:Health-care worker hand hygiene rates increase three-fold when auditors visible 3Health News:UI researchers find early predictor for preeclampsia 2Health News:UI researchers find early predictor for preeclampsia 3
... Actor Joe Pantoliano,reveals a personal history of ... untreated bipolar disorder, in a guest blog entry, ... on Mental,Illness (NAMI)., Pantoliano,s entry comes during ... days before the opening of his latest film, ...
... shows , TUESDAY, Oct. 9 (HealthDay News) -- U.S. ... to a treatment for the hereditary, progressive neurological disorder ... molecule called C2-8 appears to reduce HD-related neurological damage ... team from the MassGeneral Institute for Neurological Disorders (MIND), ...
... anxiety, low control doubles recurrent heart attack risk, study finds ... doubles the risk that someone who has had a heart ... finds. , Other studies have shown that workplace stress boosts ... anxieties with recurrent heart attacks and other major events, the ...
... scientists have developed a potentially novel way to fight ... of radiation inside cancer cells, unlike current treatments that ... the outside and cause unwanted side effects. , ... new radiation delivery system proved able to specifically target ...
... 9 The March of,Dimes congratulates Mario R. Capecchi, ... Smithies, D.Phil., FRS, former recipients of the,March of Dimes ... in Physiology or Medicine. The Nobel Committee announced ... of principles for introducing specific gene,modifications in mice by ...
... Oct. 9 Health plans are expecting premium,rate increases ... last,year,s expectation of 8.2%. This is the fourth consecutive ... conducted this survey in September of 2007. The survey,contained ... nationwide. Separately, the survey notes that the East ...
Cached Medicine News:Health News:Actor Joe Pantoliano Discloses Depression; Talks About His Latest Movie and His Sensitive Side 2Health News:Molecule Promising Against Huntington's Disease 2Health News:Stressful Jobs Hard on the Heart 2Health News:Stressful Jobs Hard on the Heart 3Health News:Inside job: new radioactive agents for colon cancer work inside cells 2Health News:Nobel Honors 3 Former March of Dimes Prize Recipients 2
... over 20 years of experience in ... the Life Sciences, the Freedom EVO ... possibilities for expansion according to future ... software, Freedom EVOware, each system is ...
... EVO Clinical is an open platform for clinical ... in deck sizes of 75, 100, 150 ... instrument for your laboratory space and throughput requirements. ... features to allow new applications and to evolve ...
... liquid handling system that ... of up to three ... the same worksurface. Offered ... solutions for targeted applications ...
... The AccelNet Laboratory Automation Network ... clinical chemistry systems, an automated sample ... manager to create a single, powerful ... ideal for laboratories that need a ...
Medicine Products: