Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

National report shines light on lupus 50-year treatment drought

07.10.2009
The Lupus Foundation of America urges key stakeholders to implement report recommendations

Today, The Lewin Group, a national health care consulting firm, issued recommendations on ways to overcome the barriers that have obstructed lupus drug development resulting in no new drug approval for this disease in more than 50 years – since the Eisenhower Administration.

The recommendations are included in the report, "Overcoming Barriers to Drug Development in Lupus," which is the outcome of a 9-month study commissioned by the Lupus Foundation of America, Inc. (LFA).

The recommendations highlight the need for a national collaborative and coordinated effort among key stakeholders, including the FDA, the National Institutes of Health (NIH), researchers and scientists from academia, the LFA, and industry, to implement a range of initiatives that would create a path forward to develop a robust arsenal of safe, effective, and more tolerable treatments for this difficult to treat and devastating disease.

The report provides recommendations for each of the key stakeholders, which include expanding federal support for medical research on lupus, assessing the existing standard of care used in clinical trials, examining the interpretation of regulations pertaining to clinical trial design and related standards of evidence used to evaluate investigational drugs for lupus, expediting the discovery and validation of lupus biomarkers, and more.

As part of the research conducted to prepare this independent report, in June 2009 more than 40 international lupus experts and thought leaders from government, industry, and the scientific community convened in Washington, DC to discuss the barriers to lupus drug development. This groundbreaking effort represents the first time leaders from all sectors with a broad range of informed opinions were brought together to address the unique challenges of lupus drug development and ways to overcome them.

Lupus is a chronic, severe autoimmune disease that affects approximately 1.5 million Americans − primarily women in their childbearing years. In its more severe form lupus can lead to kidney failure, heart attack, atherosclerosis, or even death. According to the report, lupus "stands apart" from other chronic autoimmune diseases because the majority of therapies currently used to effectively manage lupus have not been approved by the FDA for the disease. Many of these medications often have side effects that can be worse than the primary disease, including osteoporosis, weight gain, high blood pressure, diabetes, sterility, liver damage, and the increased risk of infection.

"The recommendations are a call to action requiring the efforts of all key stakeholders," said Sandra C. Raymond, LFA President and CEO. "They provide the foundation for developing and obtaining approval for the arsenal of therapies and personalized treatment that people with this perilous disease require."

The report states that the persistent lack of success of lupus clinical trials has consequences for the willingness of drug manufacturers to pursue FDA approval and indicates "some in industry perceive no clear pathway or system in place for the development of lupus therapies."

"The report findings demonstrate that the pharmaceutical and biotechnology industries cannot develop lupus treatments in a vacuum," said Rick Goulburn, Executive Vice President - Global Autoimmune Therapy Area at Vifor Pharma. "We need more collaboration and partnership across all sectors of the field, greater investment by the federal government in basic lupus research, and continued leadership from the LFA and the entire scientific community."

Lupus drug development has had many setbacks in recent years including the failure of several promising new treatments. However, much has been learned from these trials and potentially greater insight can be gained if the data is evaluated collectively.

An immediate outgrowth of the expert panel meeting held in June is the LFA Collective Data Analysis Initiative (LFA CDAI), chaired by Kenneth Kalunian, M.D., Professor of Medicine, Division of Rheumatology, Allergy and Immunology, at the University of California, San Diego, to advance the knowledge of lupus and optimize clinical trial design by researching data from previous and existing lupus clinical trials.

"The lupus community certainly recognizes the urgent need for collaboration," said Dr. Kalunian. "Following the expert panel meeting, working groups were immediately established to begin tackling the recommendations that were identified. When fully implemented, these initiatives will help gain needed insight on the issues which have plagued lupus clinical trials and develop more effective ways to design them, so ultimately lupus trials can be completed successfully."

About the LFA

The Lupus Foundation of America, Inc. is the foremost national nonprofit voluntary health organization dedicated to finding the causes of and cure for lupus, and providing support, services, and hope to all people affected by lupus. The LFA and its national network of chapters and support groups operate programs of research, education, and advocacy.

Maggie Maloney | EurekAlert!
Further information:
http://www.lupus.org

More articles from Health and Medicine:

nachricht The end of pneumonia? New vaccine offers hope
23.10.2017 | University at Buffalo

nachricht Scientists track ovarian cancers to site of origin: Fallopian tubes
23.10.2017 | Johns Hopkins Medicine

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Salmonella as a tumour medication

HZI researchers developed a bacterial strain that can be used in cancer therapy

Salmonellae are dangerous pathogens that enter the body via contaminated food and can cause severe infections. But these bacteria are also known to target...

Im Focus: Neutron star merger directly observed for the first time

University of Maryland researchers contribute to historic detection of gravitational waves and light created by event

On August 17, 2017, at 12:41:04 UTC, scientists made the first direct observation of a merger between two neutron stars--the dense, collapsed cores that remain...

Im Focus: Breaking: the first light from two neutron stars merging

Seven new papers describe the first-ever detection of light from a gravitational wave source. The event, caused by two neutron stars colliding and merging together, was dubbed GW170817 because it sent ripples through space-time that reached Earth on 2017 August 17. Around the world, hundreds of excited astronomers mobilized quickly and were able to observe the event using numerous telescopes, providing a wealth of new data.

Previous detections of gravitational waves have all involved the merger of two black holes, a feat that won the 2017 Nobel Prize in Physics earlier this month....

Im Focus: Smart sensors for efficient processes

Material defects in end products can quickly result in failures in many areas of industry, and have a massive impact on the safe use of their products. This is why, in the field of quality assurance, intelligent, nondestructive sensor systems play a key role. They allow testing components and parts in a rapid and cost-efficient manner without destroying the actual product or changing its surface. Experts from the Fraunhofer IZFP in Saarbrücken will be presenting two exhibits at the Blechexpo in Stuttgart from 7–10 November 2017 that allow fast, reliable, and automated characterization of materials and detection of defects (Hall 5, Booth 5306).

When quality testing uses time-consuming destructive test methods, it can result in enormous costs due to damaging or destroying the products. And given that...

Im Focus: Cold molecules on collision course

Using a new cooling technique MPQ scientists succeed at observing collisions in a dense beam of cold and slow dipolar molecules.

How do chemical reactions proceed at extremely low temperatures? The answer requires the investigation of molecular samples that are cold, dense, and slow at...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

3rd Symposium on Driving Simulation

23.10.2017 | Event News

ASEAN Member States discuss the future role of renewable energy

17.10.2017 | Event News

World Health Summit 2017: International experts set the course for the future of Global Health

10.10.2017 | Event News

 
Latest News

Microfluidics probe 'cholesterol' of the oil industry

23.10.2017 | Life Sciences

Gamma rays will reach beyond the limits of light

23.10.2017 | Physics and Astronomy

The end of pneumonia? New vaccine offers hope

23.10.2017 | Health and Medicine

VideoLinks
B2B-VideoLinks
More VideoLinks >>>