Navigation Links
Anthera Completes Special Protocol Assessment With FDA and Receives EMEA Scientific Advice on Development Path Toward Varespladib Approval
Date:9/24/2008

SAN MATEO, Calif., Sept. 24 /PRNewswire/ -- Anthera Pharmaceuticals announced today they have reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase 3 protocol for varespladib (A-002) in acute coronary syndrome (ACS) under the FDA's Special Protocol Assessment procedure. At the same time, the company received Scientific Advice from the European Medicines Agency (EMEA) on Anthera's European development strategy for varespladib. Guidance from both regulatory agencies regarding varespladib will be incorporated into Anthera's global registration program slated to start next year.

Anthera's Special Protocol Assessment supports a single, pivotal, Phase 3 trial evaluating varespladib, in combination with Lipitor(R) (atorvastatin) as first-line treatment within 96 hours of an ACS event. In the European Union, Anthera received Scientific Advice that supports a similar clinical development program and include the potential to also utilize varespladib as an adjunctive treatment in patients with stable coronary disease and elevated levels of LDL-C and total cholesterol.

"We are pleased that both agencies recognized the potential of varespladib's multiple therapeutic effects in patients with cardiovascular disease," said Paul Truex, President and Chief Executive Officer of Anthera Pharmaceuticals, Inc. "The anti-inflammatory effect and safety profile seen in the varespladib trials to date are very exciting and highlight the opportunity to help patients with recent coronary events."

"The regulatory clarity in the United States and Europe reinforces our confidence that we can efficiently deliver a novel therapeutic for patients with ACS," said Dr. Ursula Fritsch, Vice-President Global Regulatory and Compliance. "With this regulatory feedback, we have a clearly defined and reasonable development path to deliver a first in class therapeutic for ACS patients and individuals with hypercholesterolemia."

"The recent publication o
'/>"/>

SOURCE Anthera Pharmaceuticals
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Anthera Pharmaceuticals Advances Global Development Strategy for Varespladib in Patients With Acute Coronary Syndrome With the Initiation of FRANCIS Trial
2. DSMB Supports Continuation of Anthera Phase II Impacts Trial for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
3. Anthera Enters Into Manufacturing Agreements for Varespladib in Preparation for Pivotal Phase III Trials
4. Anthera Announces Preliminary Positive Results From Once-Daily A-002 Phase II Cardiovascular Trial
5. Antheras A-001 Receives Orphan Drug Status for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
6. Anthera Announces Positive Phase II Clinical Results From A-002 Cardiovascular Disease Trial
7. Anthera Announces Completion of Enrollment and Dosing in Phase II Trial of A-002 for the Treatment of Cardiovascular Disease
8. Arpida Completes Enrolment in Phase II "Intravenous-to-Oral" Switch Trial With Oral Iclaprim
9. Merck Serono Completes Enrollment in the REFLEX Trial of Rebif(R) in Patients at Risk of Developing Multiple Sclerosis
10. CuraGen Completes Enrollment in Phase II Trial of CR011-vcMMAE in Metastatic Melanoma
11. Human Genome Sciences Completes Enrollment in Second Phase 3 LymphoStat-B(R) Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... CVS Caremark Corporation (NYSE: CVS ) ... quarterly dividend of $0.275 (27.5 cents) per share on the ... 2014, to holders of record on July 21, 2014. ... dedicated to helping people on their path to better health ... United States . Through the company,s more than 7,600 ...
(Date:1/15/2014)... , Jan. 15, 2014 Most osteoporosis patients want ... a recent online survey* sponsored by Mission Pharmacal Company. ... National Osteoporosis Foundation online support community, revealed that 74 ... that comes in a form other than a pill ...
(Date:1/15/2014)... 2014  Novation, the leading health care supply chain expertise, ... reseller (VAR) national contracts that expand its portfolio to ... lower costs. These include manufacturer product and service agreements, ... and ongoing IT consulting support. New ...
Breaking Medicine Technology:Mission Pharmacal Conducts Online Survey of Osteoporosis Patients 2Mission Pharmacal Conducts Online Survey of Osteoporosis Patients 3New Novation Information Technology VAR Contracts Offer Significant Savings to Hospitals 2
(Date:7/13/2014)... According to the Kidney Disease Solution book review recently ... on what to do to eliminate the root cause ... its review that readers can easily learn what foods to ... health. Vkool also informs in its Kidney Disease Solution review ... functions naturally. The book consists of a collection of natural ...
(Date:7/13/2014)... Hope Palliative & Hospice Care announced today that they will ... Senior Living Community in Palatine, IL. The group, called “New ... Wednesdays of every month. This group will begin on ... 55 S. Greeley St. Palatine, IL 60067. It is ... for the group. , “A grief support group is ...
(Date:7/12/2014)... According to the new market research ... Systems, and Naval Systems) - Global Forecasts and Analysis ... Surveillance Radar market are estimated to be $6.08 billion ... of 5.97% to reach $8.61 billion by 2020. , ... figures spread through 161 pages and in-depth TOC on ...
(Date:7/12/2014)... 2014 Fresh off their respective performances in ... meet on September 5th at Sun Life Stadium in an ... some of the brightest stars in the world of football ... will be treated to some of the best talent in ... as the third best team in the world according to ...
(Date:7/12/2014)... (PRWEB) July 12, 2014 ... research report, ‘cognitive assessment and training’ is ... monitor, assess, train, or enhance cognitive functions. ... such as in dementia screening, clinical trials, ... classroom learning, self assessment, brain training, and ...
Breaking Medicine News(10 mins):Health News:Kidney Disease Solution Book Review Exposes Duncan Capicchiano's Newly Updated Kidney Disease Treatment Plan – Vkool.com 2Health News:Kidney Disease Solution Book Review Exposes Duncan Capicchiano's Newly Updated Kidney Disease Treatment Plan – Vkool.com 3Health News:Hope Hospice Announces Grief Support Group at the Tamarack Senior Living Community 2Health News:Security and Surveillance Radar Market Estimated to Reach $8.61 Billion by 2020 – New Report by MarketsandMarkets 2Health News:Security and Surveillance Radar Market Estimated to Reach $8.61 Billion by 2020 – New Report by MarketsandMarkets 3Health News:Security and Surveillance Radar Market Estimated to Reach $8.61 Billion by 2020 – New Report by MarketsandMarkets 4Health News:Brazil Vs. Colombia Tickets Sun Life Stadium: Ticket Down Slashes Ticket Prices for Friendly Match Between Colombia and Brazil 2Health News:Brazil Vs. Colombia Tickets Sun Life Stadium: Ticket Down Slashes Ticket Prices for Friendly Match Between Colombia and Brazil 3Health News:Global Cognitive Assessment & Training Market: 27.3% CAGR to 2018 Says a New Research Report Available at LifeScienceIndustryResearch.com 2Health News:Global Cognitive Assessment & Training Market: 27.3% CAGR to 2018 Says a New Research Report Available at LifeScienceIndustryResearch.com 3Health News:Global Cognitive Assessment & Training Market: 27.3% CAGR to 2018 Says a New Research Report Available at LifeScienceIndustryResearch.com 4Health News:Global Cognitive Assessment & Training Market: 27.3% CAGR to 2018 Says a New Research Report Available at LifeScienceIndustryResearch.com 5
... PHILADELPHIA Black cardiac arrest victims are more likely to ... large black population than when they,re brought to hospitals with ... from the University of Pennsylvania School of Medicine. The study ... Heart Journal . The Penn team found that, among ...
... INDIANAPOLIS William M. Tierney, M.D., president and CEO ... effectiveness research at the Indiana University School of Medicine, ... Clinical and Translational Research and Education Meeting on April ... National Award for Career Achievement and Contribution to Clinical ...
... Rockville, MD The Association for Research in Vision and ... recipients. These award recipients will be acknowledged at the ARVO ... Fla. Proctor Medal: Robert E. Anderson, MD, PhD, ... de Jong, MD, PhD, FEBOpht, FARVO, Friedenwald Award: James T. ...
... News) -- Women in powerful positions are just as likely as ... It,s widely believed that men are more likely than women to ... important factor than gender, according to the study published April 28 ... a lot of research in the past that indicates that gender ...
... scan with IV contrast and rectal balloon is highly ... values in prostate cancer patients with a rising or ... presented April 29, 2011, at the Cancer Imaging and ... by the American Society for Radiation Oncology (ASTRO) and ...
... combining a patient,s CT scans and 3D printing technology ... printing technology is a fast and affordable way to ... to transform ultra high-resolution CT patient images into 3D ... in architecture, engineering and construction. An advantage of 3-D ...
Cached Medicine News:Health News:Black cardiac arrest patients more likely to be admitted to hospitals with lowest survival rates 2Health News:Tierney named 2011 Clinical and Translational Research Distinguished Investigator 2Health News:2011 ARVO Award recipients honored at annual meeting 2Health News:2011 ARVO Award recipients honored at annual meeting 3Health News:Powerful Women as Likely to Cheat as Men, Study Finds 2Health News:MRI locates prostate cancer recurrence at extremely low PSA levels 2
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: