Navigation Links
FDA Advisers Consider New Lupus Drug
Date:11/16/2010

By Steven Reinberg
HealthDay Reporter

TUESDAY, Nov. 16 (HealthDay News) -- U.S. Food and Drug Administration advisers were weighing Tuesday whether to recommend the first new drug in more than 50 years to treat the autoimmune disease lupus.

The drug, belimumab (Benlysta), is a so-called monoclonal antibody drug developed to treat patients who suffer from systemic lupus erythematosus.

In research papers submitted to the advisory committee, the full FDA expressed some concerns about the efficacy and safety of the drug.

"I really do think the drug is efficacious," said Sandra C. Raymond, president & CEO of the Lupus Foundation of America, who was attending the advisory panel meeting. "What I'm hearing in terms of efficacy is pretty strong."

The FDA said it wants the advisory panel to look at both the efficacy data, which according to the agency is modest, and the safety data, which the agency believes raises some serious issues. Specifically, the drug has been linked to depression and suicide.

Raymond noted that many patients with lupus suffer from depression. And many patients in clinical trials testing the drug were also taking antidepressants, she added.

The advisory committee is scheduled to vote on whether the drug's risks are mitigated by the benefits it has to offer to patients who are already receiving standard care.

The agency said it is basing its concerns on the results of two phase 3 trials that compared Benlysta with a placebo.

"The risks associated with belimumab include infection, malignancy, suicidality, and overall number of deaths with a numerical imbalance that favored placebo treatment over belimumab treatment," according to the FDA.

Safety is important, Raymond said, but the drugs used to treat lupus now carry some significant side effects, too. "The safety of some of our medications is not good," she said. "So what are we comparing it to?"

The current treatments include chemotherapy and steroids, which can leave the door open to infections, cancers and other unwanted consequences, Raymond said.

Dr. Joan Merrill, head of Clinical Pharmacology at the Oklahoma Medical Research Foundation and medical director of the Lupus Foundation of America, added that "the safety data on Benlysta looks better than we usually see with biologics."

"We have to keep in mind that there is a natural ceiling on the percentage of patients who can respond to any targeted treatment. We do not yet know exactly how good Benlysta is," Merrill said.

What is known is that Benlysta was shown to be statistically superior to a placebo in two phase 3 trials, she said.

"I hope that the FDA will be able to approve it, after they complete the serious deliberations that they must make on all the data," Merrill said.

Lupus is an autoimmune disease in which the body produces antibodies that attack and destroy healthy tissue. This can damage joints, skin, blood vessels and organs. Benlysta works by inhibiting the production of these antibodies.

Benlysta is made by Human Genome Sciences and GlaxoSmithKline.

While the FDA is not bound by its advisory committees' recommendations it usually does so.

More information

To learn more about lupus, visit the Lupus Foundation of America.

SOURCES: Sandra C. Raymond, President & CEO, Lupus Foundation of America; Joan Merrill, M.D., head, Clinical Pharmacology, Oklahoma Medical Research Foundation, Medical Director, Lupus Foundation of America


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Advisers Back Anemia Drugs for Kidney Patients
2. FDA Advisers Consider Approval of Genetically Modified Salmon
3. FDA Advisers Weigh Approval of Genetically Modified Salmon
4. FDA Advisers Divided on Whether to Ban Diet Drug Meridia
5. FDA Advisers Say Avastin Shouldnt Be Used for Breast Cancer
6. FDA to Broaden Disclosure on Advisers Conflicts of Interest
7. FDA Advisers Urge Stricter Regulation of Tanning Beds
8. Considerable proportion of patients with advanced cancer continue to undergo common cancer screening
9. ConnectedIn Divorce Resource Offers Online Expert Website for People Considering or Going Through Divorce
10. BMEGateway's 20th Anniversary Insurance Symposium considered a “Tremendous” Success
11. Newly Relaunched Autoinsurance.net Offers Consumers Smart Tips To Consider When Purchasing Car Insurance
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Advisers Consider New Lupus Drug
(Date:6/25/2016)... , ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on ... Observer , brings up a new, often overlooked aspect of head lice: the parasite’s ability ... fumigation is not a common occurrence, but a necessary one in the event that lice ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... recover from injury. Recently, he has implemented orthobiologic procedures as a method for ... is one of the first doctors to perform the treatment. Orthobiologics are substances ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may ... to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To ... for healthy coping following a traumatic event. , Trauma sufferers tend to feel a ...
(Date:6/24/2016)... ... 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 ... by their peers for this recognition are considered among the top 2 percent of ... honors as members of this year’s Legal Elite Hall of Fame: Miami Shareholders ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening ... Talker Award, an essay contest in which patients and their families pay tribute to ... at the 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... 2016 Story Highlights: ... within the health care industry is causing providers to ... , Deloitte offers a suite of solutions for health ... efficient cost optimization: labor resource analysis, revenue cycle optimization ... better outcomes and better economics ...
(Date:6/24/2016)... , June 24, 2016  Collagen Matrix, Inc., ... development and manufacturing of collagen and mineral based ... today that Bill Messer has joined ... to further leverage the growing portfolio of oral ... Bill joins the Collagen Matrix executive ...
(Date:6/24/2016)... , June 24, 2016   Bay Area ... Network,s Dean Center for Tick Borne Illness ... and Rehabilitation, MIT Hacking Medicine, University of California, ... today announced the five finalists of Lyme ... disease.  More than 100 scientists, clinicians, researchers, entrepreneurs, ...
Breaking Medicine Technology: