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Interesting Results…

Gene That Boosts Resistance to Malaria linked to Susceptibility to MS and Lupus in Sardinia

Researchers from Italy found a strong association between the gene that instructs the molecule “BAFF” and susceptibility to MS and lupus in studies of nearly 6,000 people in Sardinia. The BAFF gene is crucial to activation of immune B cells and is also associated with resistance to malaria. Malaria was common in Sardinia until it was eradicated in 1950. The rates of MS and certain immune-mediated diseases are high in Sardinia. Further research is necessary to confirm whether this high rate is related to BAFF, and whether MS could be treated by a therapy that targets BAFF.

Read more about this study from the Genetic Literacy Project

Read the scientific summary of the paper in The New England Journal of Medicine

Read more about efforts to end MS forever

 
 

Novel Protein Identified Inside Cells During MS Inflammation May Help Explain Nerve Damage

Researchers from the University of Alberta in Canada report that levels of Rab32 – a protein that directs traffic between cell organs – are increased in sites of active inflammation in brain tissue obtained from people with MS and in mouse models of MS-like disease. This increase was linked to the destruction of nerve cells. If the results are confirmed, this knowledge could explain part of the neurodegenerative process that leads to progression of disability in MS and could be a target for development of effective MS treatments.

Read more on ReliaWire
Read the open access paper in Journal of Neuroinflammation
Read more about Research to stop MS in its tracks

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Researchers Recruiting African Americans with MS Across the U.S. for Genetics Studies – Key to finding cause of MS and better treatments

Rationale: Genes are known to play a role in determining who is susceptible to developing multiple sclerosis, and may also influence the course of the disease. People living with MS can make a difference in studies searching for these genes by donating their DNA from blood samples. Identifying the exact location of MS genes could help determine who is at risk for developing the disease and may provide clues to its cause, prevention, and better treatment. Focusing on ethnic groups with lower susceptibility to MS (such as African-Americans) and higher susceptibility (such as individuals of Northern European descent), and searching for what is common and what is different in their genes may help pinpoint regions that contain MS genes. Large numbers of participants are needed to accelerate this research.

Details: It is not necessary to travel to San Francisco to participate in this study. Once an individual has completed the initial online intake form and has agreed to participate, they are emailed the links to two additional online forms and sent a kit via express mail. The kit includes a consent form, a health information privacy form, and a medical records release form. The kit also includes everything necessary for the blood draw, which can be taken to your local Quest Diagnostics Lab, where the blood can be drawn and then returned in a prepaid envelope to the UCSF MS Genetics Lab. There is no cost to the study participants.

Contact: To participate or request additional information, please complete our brief intake survey.

OR you may contact us directly:

Clinical Research Coordinator
UCSF Multiple Sclerosis Genetic Susceptibility Project
675 Nelson Rising Lane, Suite 235A, Box 3206
San Francisco, CA 94158
Email: msdb@ucsf.edu
Website: http://msgenetics.ucsf.edu/index.html
Toll Free Phone: 1-866-MS-Genes (1-866-674-3637)

Study Finds That Some Family Members of People with MS Show Possible Early Signs of the Disease without Symptoms

Summary

  • As part of a large-scale “Genes & Environment in MS” (GEMS) study to understand factors that lead to the development of multiple sclerosis, researchers analyzed the genes and backgrounds of individuals who had no symptoms of MS, but who had close family members with MS.
  • Based on that analysis, researchers identified a group of 40 women at higher risk for developing MS, and 25 women at lower risk. Extensive neurological testing and MRI scanning uncovered possible neurological abnormalities in the higher risk group, and MRI abnormalities in a small proportion of both groups.
  • “At this time, we are developing strategies to manage the risk of MS, but there is, as yet, no specific recommendation,” explains co-author Dr. Phillip De Jager. “Family members should be reassured that the vast majority of family members will not develop MS.”
  • The team (including Zongqi Xia, MD, PhD, of Brigham and Women’s Hospital, and Daniel S. Reich, MD, PhD, of National Institute of Neurological Disorders and Stroke, Bethesda, MD) has published results in JAMA Neurology (published online January 17, 2017).
  • This study was supported by the National MS Society and the National Institutes of Health, and the Society helped to recruit participants. Two of the study authors – Daniel S. Reich, MD, PhD, and Philip L. De Jager, MD, PhD – are winners of the prestigious Barancik Prize for Innovation in MS Research.

Background: An individual’s risk of developing MS increases if a close family member has MS. There is currently no way to predict which family members will develop MS. The goal of the Genes & Environment in MS (GEMS) study is to identify the genetic, environmental and immune profiles that may increase a person’s risk of developing MS.  Researchers are recruiting 5,000 subjects who have at least one first-degree relative with a diagnosis of MS. The GEMS Study is gathering genetic material (DNA) and environmental exposure history from participants as well as blood samples and brain magnetic resonance imaging (MRI) as an option. Investigators are classifying participants using the Genetic and Environmental Risk Score for MS Susceptibility (GERSMS), an experimental approach which incorporates genetic information and environmental exposures to identify people at higher or lower risk of developing MS.

The Study: As part of this large-scale, ongoing study, researchers looked at 65 women who are first-degree relatives of people with MS. The GERSMS indicated that 40 of these women were at higher risk of developing MS, and 25 women were at lower risk of developing MS. These women underwent a comprehensive neurologic examination and MRI scans.

Women in the higher risk group had less than normal vibration sensitivity in their big toes, a finding that indicates potential nerve dysfunction. A small percentage of the women in both groups had more MRI abnormalities associated with MS than one would expect to find in the general population.

The team (Zongqi Xia, MD, PhD, of Brigham and Women’s Hospital, Boston, MA, and Daniel S. Reich, MD, PhD, of National Institute of Neurological Disorders and Stroke, Bethesda, MD) has published results in JAMA Neurology (published online January 17, 2017).

This study was supported by the National MS Society and the National Institutes of Health, and the Society helped to recruit participants. Two of the study authors – Daniel S. Reich, MD, PhD, and Philip L. De Jager, MD, PhD – are winners of the prestigious Barancik Prize for Innovation in MS Research.

Next Steps:  In this study, women at high risk for MS showed possible early manifestations of the disease. “The goal of the Genes & Environment Study is to understand the sequence of events that leads someone to develop MS,” explains co-author Dr. De Jager. “At this time, we are developing strategies to manage the risk of MS, but there is, as yet, no specific recommendation. Family members should be reassured that the vast majority of family members will not develop MS.” He notes that the study did not test the possibility of preventive strategies, such as vitamin D supplementation.  “Taking vitamin D is good for bone health, and MS family members should discuss taking such supplements with their physician.”

Read more about research to find the genetic and environmental underpinnings of MS

 

An FDA Approved Generic Form of Copaxone® (Glatiramer Acetate) For Relapsing MS Called Glatopa™ Is Launched In the U.S.

A generic equivalent of daily Copaxone® (glatiramer acetate, 20 mg), called “Glatopa”™ (Sandoz, a Novartis company, developed in collaboration with Momenta Pharmaceuticals) that was approved by the U.S. Food and Drug Administration in April, has been launched in the U.S. Glatopa is a disease-modifying therapy for people with relapsing forms of MS, including those who have experienced a first clinical episode and have MRI features consistent with MS.

The generic medication is a 20mg dose injected under the skin every day. This approval means that the manufacturer provided evidence that this generic medication is equivalent to the brand-name drug (Copaxone®).

According to Novartis which owns Sandoz, Glatopa would have a wholesale list price of about $63,000 per year. This is an estimated 15- 18 percent less than the list price of daily Copaxone. Sandoz advises that it will offer support services that include financial assistance to qualified patients, personalized injection training and 24-hour access to nurses for non-clinical questions, services not typically offered for generic medications.

“Having a generic option for one of the MS disease-modifying therapies is an important milestone, and it has the potential to increase access to MS therapies,” commented Dr. Bruce Bebo, Executive Vice President, Research at the National MS Society. “As more generic and biosimilar options become available, we are hopeful that we will start to see some price relief for people living with MS” he added.

“Health care professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in an FDA press release. “Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product.” The FDA’s press release provides additional details (available here) related to how the agency determined the generic’s equivalency.

Selecting a therapy should be done by people with MS in collaboration with their MS doctors, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.

About Glatopa: The FDA has approved a generic medication that has been shown to be equivalent to 20mg daily glatiramer acetate. Glatopa is not a generic version of the 40mg dose of Copaxone taken every three days. Glatiramer acetate is a synthetic protein that mimics myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord. This therapy seems to block myelin-damaging T-cells through a mechanism that is not completely understood. The approved generic form of glatiramer acetate is given by subcutaneous (under the skin) injections every day.

Potential benefits: In clinical trials of glatiramer acetate, it was shown to significantly reduce annual relapse rates and new brain lesions as shown on magnetic resonance imaging (MRI), when compared to those who were given a placebo. This therapy has had a long track record of effectiveness and safety.

As part of the generic medication approval process, the FDA requires that generics have the same active ingredients, strength, dosage and mode of administration as the brand-name medication, and that they are manufactured according to federal quality control regulations. Clinical trials are generally not required to prove equivalence to a brand-name medication.

Potential risks and side effects: Side effects of glatiramer acetate that generally resolve on their own and do not require medical attention unless they continue for several weeks or are bothersome include injection-site reactions (e.g., swelling, the development of a hardened lump, redness, tenderness, increased warmth of the skin, itching at the site of the injection); runny nose; tremor; unusual tiredness or weakness; and weight gain. There is also the potential for local damage to the skin (necrosis) and underlying tissue (lipoatrophy).

Some people using glatiramer acetate experience, at one time or another, a very temporary reaction immediately after injecting glatiramer acetate. This reaction, which often occurs only once, includes flushing or chest tightness with heart palpitations, anxiety, and difficulty breathing. During the clinical trials, these reactions occurred very rarely, usually within minutes of an injection. They lasted approximately 15 minutes and resolved without further problem.

Unusual side effects of glatiramer acetate that should be discussed as soon as possible with your doctor include hives (an itchy, blotchy swelling of the skin) or severe pain at the injection site.

The National MS Society will provide more information about generic glatiramer acetate as it becomes available.

Download prescribing information (.pdf)
Read a press release from the FDA
Read more about disease-modifying therapies and other treatments for MS and MS symptoms.

Frequently Asked Questions: Approval of Generic Glatiramer Acetate

When will generic glatiramer acetate be available for prescription?

  • There is no information yet about when this medication, called Glatopa, will be available for prescription in the United States.

What will the generic glatiramer acetate cost?

  • Though we don’t have specific costs of Glatopa at this time, according to Novartis which owns Sandoz, the product would have a wholesale list price of about $63,000 per year.

What does it mean for a therapy to go generic – will Copaxone still be available for prescription?

  • As patent protections expire for Copaxone, other manufacturers are free to replicate it and seek drug regulatory agency approval to market it.
  • For many medications available as generics, the brand-name medications remain on the market. From the information currently available, it is expected that Copaxone will continue to be available by prescription in both the 20mg once daily dose, and the 40mg dose taken every three days.

What about insurance coverage for the generic or for Copaxone – will I be forced to switch from my current medication?

  • Coverage of prescriptions differs among various insurers. At this point we don’t know how insurers will handle coverage of Copaxone versus generic glatiramer acetate.

Does this generic medication 20mg dose have the same therapeutic benefit as 20 mg Copaxone?

  • The FDA has a thorough review process and guidelines in place to evaluate the equivalence of proposed generic drugs to brand name drug products.
  • If the FDA reviews and approves a generic medication, it means the medication’s maker has provided sufficient evidence that the generic will have the same therapeutic benefits as the brand-name product.
  • The U.S. FDA is empowered by Congress to evaluate generic drug candidates through Abbreviated New Drug Applications.
  • The National MS Society has confidence in the FDA’s processes.

Will patient support services be available to people who are prescribed Glatopa?

  • According to Sandoz, it will offer support services that include financial assistance to qualified patients, personalized injection training, and 24-hour access to nurses for non-clinical questions.

Frequently Asked Questions: Generic Therapies for the Treatment of MS

The MS therapy landscape is continuously evolving. Two decades ago there were no disease-modifying therapies available, and now there are more than a dozen. We have also reached the point where “generic” versions of MS therapies are entering the marketplace. The following provides information about generic drugs and what they may mean for the MS community.

What is a generic medication?

  • A generic medication is a product that is equivalent to a brand-name drug whose patent protections have expired.
  • As part of the generic medication approval process, the FDA requires that generics have the same active ingredients, strength, dosage and mode of administration as the brand-name medication, and that they are manufactured according to federal quality control regulations.
  • Generic makers are required to show that the generic drug delivers the same amount of active ingredients to the person’s bloodstream in the same amount of time as the brand-name product (referred to as “bioequivalency”).

What is the Society’s view of generic therapies for MS?

  • The National MS Society advocates for increased treatment options for people with all forms of MS. Early and ongoing treatment is currently the best known way to reduce future disease activity.
  • Having approved generics has the potential to increase individuals’ access to MS therapies and provides the MS community with more options.

Does the National MS Society recommend the use of this new generic MS therapy?

  • The National MS Society does not make individual treatment recommendations, but as we do for all other approved therapies, we make information available to constituents so that they can make informed decisions about their treatment choices.

Do generic medications have the same therapeutic benefit as name-brand medications?

  • The FDA has a thorough review process and guidelines in place to evaluate the equivalence of proposed generic drugs to brand name drug products.
  • If the FDA reviews and approves a generic medication, it means the medication’s maker has provided sufficient evidence that the generic will have the same therapeutic benefits as the brand-name product.
  • The U.S. FDA is empowered by Congress to evaluate generic drug candidates through Abbreviated New Drug Applications.
  • The National MS Society has confidence in the FDA’s processes.

Will there be equivalent medications for all MS therapies?

  • It’s possible that eventually there will be. But before any medication may be copied, the patents protecting the brand-name medication must expire. Then a maker of equivalent medications would need to apply to the FDA with a request for approval of its medication.
  • The term “generic” technically applies to products that are considered drugs made through a chemical manufacturing process. Some of the MS therapies are classified as chemical drugs, and so when their patents expire, they would likely be eligible to be manufactured as generics. These FDA-approved therapies are classified as chemical drugs: Aubagio, Copaxone, Gilenya and Tecfidera.
  • The other MS therapies — Avonex, Betaseron, Extavia, Lemtrada, Plegridy, Rebif, and Tysabri — are technically classified as “biologics.” Biologics are generally more complex and they are made from human or animal materials rather than chemical processes. The technical term for equivalent medications for biologics is “biosimilar” or “follow-on biologic.”
  • The FDA has long-established requirements for the approval of generic medications, and has recently released guidelines related to the approval of biosimilars.

What is the current progress toward developing equivalent medications for MS therapies?

  • The FDA just approved a generic form of glatiramer acetate, and the agency has received Abbreviated New Drug Applications for other generic forms of this medication.
  • With the exception of Novantrone and Copaxone, no other disease-modifying MS medications are available in a generic form.

Where can I get more information about generic drugs and biosimilars?

The FDA’s Website has information about generic drugs and biosimilars and processes for their approval.

Copaxone is a registered trademark of Teva Pharmaceutical Industries LTD.
Glatopa is a trademark of Novartis AG

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