BG-12 (Tecfidera) FDA approved March 28, 2013 – Pill

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Tecfidera (BG-12) Approved for the Long-Term (RRMS)Treatment of MS

March 28, 2013

The United States Food and Drug Administration (FDA) announced on March 27, 2013 that it has approved Tecfidera™ (dimethyl fumarate or DMF, formerly known as BG-12) as a first-line therapy for the long-term treatment of relapsing forms of multiple sclerosis (MS). Tecfidera’s parent company, Biogen Idec, submitted a New Drug Application (NDA) to the FDA for the approval of this drug in February 2012. (Read the FDA’s press release on the approval of Tecfidera.)

Before taking and while you take TECFIDERA, tell your doctor if you have or have had:  Low White blood cell counts or an infection and ay other medical conditions.

Tecfidera is the 10th drug to be approved as a disease-modifying therapy (DMT) for the long-term treatment of MS. Tecfidera is administered in pill form orally (by mouth) and is the third oral DMT approved for MS. The approved dosage is 240 mg to be taken two-times daily. The previous oral medications were approved in 2010 (Gilenya®) and in 2012 (Aubagio®). Five other DMTs for MS are taken via self-injection – the first of which was approved in 1993; the remaining two DMTs are administered via intravenous injection. While none of these treatments can cure MS, they all have been shown to be effective in reducing the number and severity of relapses (disease flare-ups), slow disease activity (in terms of fewer and less-active lesions in the brain), and in some instances, slow disease progression.

MSAA Chief Medical Officer Dr. Jack Burks explains, “With the FDA approval of Tecfidera, a pill taken twice daily, another first-line oral treatment option for people with relapsing forms of MS becomes available. The combination of robust effectiveness data with only transient side effects consisting mainly of flushing and gastrointestinal symptoms adds another valuable treatment option for patients and doctors to discuss. The future for individuals with MS is brighter than ever, and this is true not only for those with relapsing forms of MS, but for others also. Encouraging drug trials are currently underway in an effort to provide treatment options for the entire MS community, including those with non-relapsing, progressive forms of the disease.”

Mechanisms of Action – How Tecfidera WorksTecfidera is related to a medication called Fumaderm®, which was previously shown to be effective in patients with psoriasis and used for this indication in Germany for many years. The mechanism of action in MS is still under investigation; however, Tecfidera may have a distinct dual mechanism of action.

First, it is an immunomodulator, modulating or affecting how the immune system functions. It exhibits anti-inflammatory properties, which is an important component in the effective treatment of relapsing forms of MS. This induces anti-inflammatory cytokines (small proteins that may stimulate or inhibit the function of other cells) and appears to suppress damaging macrophage cell activity. Macrophages are a type of white blood cell that can damage both the protective covering (myelin) to the nerves of the central nervous system (those of the brain, spinal cord, and optic nerves) and can also damage the nerves themselves.

Second, Tecfidera may have neuroprotective effects, potentially protecting the nerves and their myelin covering from damage. This is due to its activation of a substance that is critical for resistance to cellular damage (from what is termed “oxidative stress”), and is also critical for normal immune function.

Completed Studies with TecfideraTwo large Phase III trials were conducted with Tecfidera; both showed positive outcomes. The Phase III DEFINE study, which compared two doses of Tecfidera against placebo in 1,200 patients, was completed in February 2011. The Phase III CONFIRM study, which enrolled 1,232 patients, tested two dose levels against placebo, and also compared Copaxone against the same placebo group; the study was completed in September 2011.

The Phase III DEFINE study was a multicenter, double-blind trial of Tecfidera. In this study, 240 mg of Tecfidera was given either twice or three times daily versus placebo for two years. The study met its primary endpoint with a 49 to 50-percent reduction in the proportion of patients who relapsed during the study period. One of the secondary clinical endpoints was confirmed disability progression. Each of the two Tecfidera doses reduced the risk of sustained disability progression (for at least 12 weeks) by 34 to 38 percent.

The Phase III CONFIRM study was also a multicenter, double-blind trial. For two years, it compared the same two doses of Tecfidera with placebo (as done in the DEFINE study) and also compared the same placebo group to a group receiving daily subcutaneous injections of Copaxone. (Please note that the study was not designed to compare the effectiveness of Tecfidera to Copaxone.) The study met its primary endpoint with a reduction in relapse rates of 44 to 51 percent for Tecfidera compared to placebo. No statistically significant difference was observed in the remaining clinical endpoint of confirmed disability progression, possibly due to the unexpectedly low rate of progression in the placebo group.

 

In both studies, compared to placebo, individuals given Tecfidera had significantly reduced disease activity as shown on magnetic resonance imaging (MRI) scans. These included significant reductions in the number and size of new and enhancing brain lesions (areas of disease activity, inflammation, and potential damage to the myelin and nerves).

Continuation StudiesA continuation study of 1,736 patients who participated in the DEFINE and CONFIRM studies called ENDORSE is evaluating the long-term safety profile of Tecfidera as well as its long-term efficacy on clinical outcomes, MRI scans, and quality-of-life. The study will continue through 2013, although initial data were presented in fall 2012. No new safety concerns were identified, and no deaths were thought to be related to the medication. There were 14 malignancies observed (less than 1 percent) in this patient population, though it was not apparent that these were directly caused by Tecfidera.

The Phase II EXPLORE trial is evaluating oral Tecfidera as a combination therapy with an injectable medication. It will determine the safety and tolerability of Tecfidera when administered in combination with interferons or Copaxone to 100 people (who continue to have evidence of disease activity despite receiving consistent treatment for at least one year). Efficacy endpoints (determining the effectiveness) will also be assessed in a subset of participants. The study concluded in 2012 and the results are expected in 2013.

Side Effects and Adverse EventsIn the large studies leading up to the approval of Tecfidera, flushing and gastrointestinal events, such as diarrhea, nausea and vomiting, and abdominal pain, were the most commonly reported side effects. Flushing and gastrointestinal events occurred in approximately 30 to 40 percent of patients and occurred more often at the beginning of treatment, decreasing in frequency after the first one to two months on this medication.

Other adverse events, which were mild or moderate in severity, included upper respiratory infection, pruritus (chronic itching), and erythema (skin redness or rash). The only serious adverse events (aside from MS relapses) to occur in two or more patients taking Tecfidera during these large studies was gastroenteritis (an inflammation of the lining of the intestines) and gastritis (an inflammation of the stomach lining).

In terms of long-term health risks, reduced white-blood cell (lymphocyte) counts were seen during the first year of treatment (lymphocytes are disease-fighting cells). However, the incidence of infection did not differ between the treated and placebo groups during the studies. Because of the reduced white-blood cell counts, the FDA recommends that prior to starting Tecfidera, and annually thereafter while still on the treatment, patients be given a complete blood count to monitor their ability to fight infection.

The occurrence of malignancies were low and did not differ between treatment groups in the DEFINE trial. No malignancies were reported with the CONFIRM trial.

During the first six months of therapy in the DEFINE study, liver enzymes were elevated in 6 percent of individuals taking Tecfidera, compared to 3 percent of the placebo group. No cases of liver failure were reported in either study. Excess protein in the urine (proteinuria) was observed slightly more often in the treated groups versus the placebo group of the DEFINE study. No cases of kidney failure were reported in either study.

For More Information
Additional information on Tecfidera may be found by visiting www.tecfideraPill.com. Individuals may also learn more through Biogen Idec’s patient assistance program’s website at www.msactivesource.com or by calling (844) 825-5832. In addition to MSAA’s website (at mymsaa.org), individuals may call MSAA at (800) 532-7667 for more information about MS and its treatments. Questions to MSAA’s Client Services Department may be emailed to MSquestions@mymsaa.org.

Mar 27, 2013

Updated 4/16/13

The U.S. Food and Drug Administration has approved Tecfidera™ capsules (dimethyl fumarate, Biogen Idec –formerly “BG-12”) as a first-line disease-modifying therapy for people with relapsing forms of MS. This makes the third oral therapy approved for relapsing MS, and the tenth disease-modifying treatment available in the U.S.

“The approval of Tecfidera is an important expansion of therapeutic options, and increases our ability to find effective and tolerable treatment solutions for individual patients,” said Bruce A. Cohen, MD, Professor, Davee Department of Neurology and Clinical Neurosciences at Northwestern University’s Feinberg School of Medicine, and Chair of the National MS Society’s National Medical Advisory Committee. “As with all newly-approved treatments, we will learn more about the benefits and safety of Tecfidera over time,” he added.

“The approval of Tecfidera is encouraging news for people who have relapsing forms of MS,” noted Timothy Coetzee, PhD, Chief Research Officer at the National MS Society. “Having ten disease-modifying therapies available for relapsing forms of MS further motivates us to gather the forces of the global community to make similar strides for people with progressive forms of MS, for whom there are fewer options.” Read more about the International Progressive MS Collaborative (.pdf)

Read the FDA’s press release. Download patient information about Tecfidera.

About Tecfidera: Multiple sclerosis involves immune system attacks against brain and spinal cord tissues. Although its exact mechanism of action is not known, Tecfidera is thought to inhibit immune cells and molecules, and may have anti-oxidant properties that could be protective against damage to the brain and spinal cord. A chemically related compound, called Fumaderm (dimethyl fumarate and fumaric acid esters), has been used for decades in Germany to treat acute flare-ups of psoriasis. Tecfidera is a new, different formulation of dimethyl fumarate that was developed by Biogen Idec specifically for the treatment of multiple sclerosis.

Potential benefits: Twice-daily Tecfidera was shown in clinical trials to significantly reduce relapses and disease activity on MRIs, and in one trial it reduced progression of disability. The FDA’s approval was based largely on results of two large-scale phase III studies of Tecfidera capsules, called DEFINE and CONFIRM, which were conducted in people with relapsing-remitting MS. The results were published in 2012. Read a summary

In the DEFINE trial, there was a significant reduction in the proportion of people on Tecfidera who experienced relapses at 2 years, compared with those on inactive placebo. For those on the approved twice-daily dose, 27% experienced relapses, versus 46% of those on placebo — a 49% reduction in the risk of relapse. All secondary outcomes were also met in the Tecfidera groups, including significant impact on disease activity detected with MRI, and reduction in the risk of confirmed progression of disability (detected by the EDSS, a standard scale that measures disability). The proportion of those who progressed over two years was 16% for twice-daily Tecfidera versus 27% for placebo — a 38% reduction in risk of disability.

In the CONFIRM trial, there was a significant reduction in the average annual number of MS relapses (annualized relapse rate, or ARR) in the Tecfidera groups versus placebo. For those on the approved twice-daily dose, ARR was reduced by 44% versus placebo. Results in secondary endpoints included significant reductions in disease activity on MRI and the proportion of patients experiencing relapses in the Tecfidera groups versus placebo. Disability progression was not reduced significantly in the Tecfidera groups compared to the placebo group.

Potential risks and screenings: The most common adverse events experienced by people taking Tecfidera during the trials were flushing (which can create a sensation of heat or itching and a red blush on the skin) and gastrointestinal events (such as diarrhea, nausea, and upper abdominal pain). During the clinical trials, up to 40% of participants experienced flushing, and some experienced gastrointestinal events. The incidence of these events was highest in the first month of treatment, decreasing thereafter. Tecfidera reduced blood lymphocyte (white blood cell) counts but no significant or severe infections were reported. Liver enzyme tests were elevated, but there were no reports of significant liver injury or liver failure.

Before starting treatment, the FDA recommends that a person’s health care provider assess a recent (within 6 months) blood cell count, and repeat the blood cell count annually thereafter. Before starting treatment with Tecfidera, women should talk to their health care providers if they are pregnant or planning to become pregnant.

Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future deterioration. Selecting an MS 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.

For more information about support services provided by Biogen Idec, people can contact the company’s MS ActiveSource® Program. MS ActiveSource is available by phone at 1-800-456-2255 or on the Web at ww.MSActiveSource.com.