Drug information

RedHill Biopharma has received a Notice of Allowance for a new patent on RHB-104 its potential therapy for patients with relapsing-remitting multiple sclerosis (RRMS). Once granted by the United States Patent and Trademark Office (USPTO), this patent will be valid until 2032. RHB-104 is a proprietary, orally-administered antibiotic combination with potentially potent intracellular, antimycobacterial…

Editor’s Note: First in a two-part series on readers’ comments about Ocrevus (ocrelizumab). I switched disease-modifying therapies and began treatment with Ocrevus (ocrelizumab) in June. I previously wrote about my reasons for switching, my experiences with the first two doses, and more recently, about any…

Potential new ways of capturing disease progression in multiple sclerosis (MS) patients — including those with chronic as opposed to active inflammation — are coming to the fore as analyses continue into the huge amounts of data collected during pivotal clinical trials that led to Ocrevus’ approval, a leading Genentech researcher…

Both Ocrevus (ocrelizumab) and Rituxan (rituximab) trigger a similar release of inflammatory mediators after a first infusion, with little difference seen in infusion reactions among a small group of multiple sclerosis (MS) patients treated with either therapy, said researchers from the Rocky Mountain MS Center at the University of…

Celgene‘s investigative drug ozanimod has been shown to be more efficient than an intramuscular injection of interferon beta-1a (marketed as Avonex by Biogen) in reducing relapses and disease progression in patients with relapsing multiple sclerosis (MS), according to results of the two-year Phase 3 RADIANCE trial. The findings were…

Gilenya (fingolimod) lowered relapse rates in children and adolescents with relapsing multiple sclerosis at a “magnitude” — almost 82 percent — never before seen in a scientific study and could be “life changing” for these hard-to-treat patients, a top researcher with Novartis, the treatment’s developer, said in an…

The Japanese company MediciNova‘s anti-inflammatory agent ibudilast slows multiple sclerosis patients’ brain shrinkage and their loss of the protective myelin coating around nerve cells, a Phase 2 clinical trial shows. Robert J. Fox of Ohio’s Cleveland Clinic Neurological Institute presented the results at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25-28.

Gilenya (fingolimod) was seen to significantly reduce relapses in children and teenagers with multiple sclerosis (MS), according to data from a Phase 3 study — the first successfully conducted in pediatric patients. Novartis, the therapy’s developer, is preparing to file requests for Gilenya to be approved to…

Lemtrada (alemtuzumab) remains a “game-changer” of a treatment for relapsing multiple sclerosis (MS), with benefits continuing and no new side effects seen in a study of its use that now goes out seven years, Aaron Boster, a neuroimmunologist at Ohio Health, said in an interview at the…

This is a special edition of Multiple Sclerosis News Today's daily Alexa Flash Briefing, covering the latest news from the 7th Joint ECTRIMS-ACTRIMS Meeting currently underway in Paris, France. The MS News today team in on-site at the conference, providing exclusive coverage of the presentations and speakers.

Since the approval of the first disease-modifying drug (DMD) for MS back in the mid-1990s, another dozen or so have been added as treatment options. But, just as MS affects each patient differently, so do the drugs. Missing has been a tool to follow MS patients and their…

Long-term exposure of at least three years of beta-interferon therapies such as Rebif or Avonex may increase the survival of multiple sclerosis (MS) patients, a population-based study suggests. The study reporting the findings, titled “Beta-interferon and mortality in multiple sclerosis: a population-based international study,” was presented Friday at the ongoing ECTRIMS-ACTRIMS Meeting…

Sanofi Genzyme’s multiple sclerosis therapy Aubagio (teriflunomide) does not appear to cause birth defects in humans as it does in laboratory animals, researchers concluded after studying more than 100 pregnant women with MS. Their research indicated that birth-defect findings in rats and rabbits do not translate to humans. The team presented its…

Babies born to women who are treated with Tysabri (natalizumab) during pregnancy are more likely to develop abnormal blood cell counts if the treatment continues beyond week 30 of pregnancy. Since more relapses occurred in women who quit the treatment before this time, researchers from the Ludwig Maximilian University…

Mavenclad (cladribine tablets), an oral therapy by Merck that’s approved to treat people with active relapsing multiple sclerosis in much of Europe, is a “smart therapy” that is showing real and long-term benefit after a short treatment course, said Gavin Giovannoni, chair of neurology at Barts and The London School of Medicine…

Sanofi Genzyme‘s Lemtrada (alemtuzumab) and Biogen’s Tysabri (natalizumab) are more effective in preventing conversion to secondary progressive multiple sclerosis (SPMS) compared to older injectable drugs, researchers from the University of Cambridge in the U.K. reported at the 7th Joint ECTRIMS-ACTRIMS Meeting Oct. 25-28 in Paris. The…

There’s been some internet buzz recently about the possibility of an over-the-counter allergy drug that helps to repair the myelin that MS damages. The drug is clemastine fumarate, and I suspect that some of that buzz may have been generated by headlines found on Twitter and…

An immune signaling protein called interleukin-35 has anti-inflammatory properties that scientists might harness to develop a therapy for multiple sclerosis and other autoimmune disorders, according to two studies. Researchers at the National Eye Institute of the National Institutes of Health discovered that a subunit of interleukin 35, which is also known as IL-35, significantly reduced inflammation in mouse models of eye inflammation and multiple sclerosis. Immune B-cells produce IL-35 to communicate with, and regulate the behavior of, surrounding cells. In a previous study, the research team found that the protein could inhibit inflammation in the eyes of animals with autoimmune uveitis, or inflammation of the inner layers of the eye. An autoimmune disease is one in which the immune system attacks healthy cells instead of invaders. A drawback of trying to use a synthetic version of IL-35 as a therapy is that it's difficult to produce because of its complex structure and it's unstable in a solution. Natural IL-35 is composed of two subunits, IL-12p35 and Ebi3, which bind to create the full protein. The team wondered if they could use a subunit, instead of the full protein, as an anti-inflammatory agent. Their study, “IL-12p35 induces expansion of IL-10 and IL-35-expressing regulatory B cells and ameliorates autoimmune disease,” was published in the journal Nature Communications, They demonstrated that the IL-12p35 subunit could generate anti-inflammatory effects similar to those of the full IL-35 protein. Giving IL-12p35 to mice with uveitis promoted the expansion of immune B-cells that counteract autoimmune responses, reversing the animals' eye symptoms. In the second study, researchers discovered that the subunit tempered inflammation in a mouse model of multiple sclerosis. Giving the animals IL-12p35 every other day for up to 12 days promoted immune cell proliferation that inhibited inflammation in the mice's brains and spinal cords, improving their symptoms. The research demonstrated IL-35 and its subunit's potential to treat nerve-inflammation disorders. The team published its findings in the journal Frontiers of Immunology. The article is titled “IL-12p35 inhibits neuroinflammation and ameliorates autoimmune encephalomyelitis.” The team is now looking at IL-12p35's ability to treat other degenerative eye diseases, such as diabetic retinopathy and macular degeneration.

New data on how Lemtrada and Aubagio perform in a real-world setting will be the focus of Sanofi Genzyme when the company showcases its research at the upcoming 7th Joint ECTRIMS-ACTRIMS Meeting in Paris this week. Researchers will also share information about the safety of a new investigational therapy, GLD52 (GZ402668), currently in a Phase 1 safety study. The TOPAZ study is one of the main data sources for the upcoming presentations. The study, which follows relapsing MS patients who participated in the CARE MS-I and CARE MS-II extension study , is a rich source of information on long-term outcomes. Researchers will share various aspects of disease outcomes and magnetic resonance imaging (MRI) data from patients followed up to seven years, with some presentations focusing solely on those who switched from treatment with interferon beta-1a. Among the Lemtrada highlights are findings demonstrating that Lemtrada does not appear to trigger birth defects. Another presentation compared Lemtrada to Genentech’s Ocrevus using a model that evaluated both the cost and effectiveness of the two drugs. The analysis suggests that Lemtrada more effectively treated relapsing MS and was also linked to lower costs over a 20-year period. Aubagio studies also focused on long-term patient data, including in people with progressive forms of relapsing MS. Data from the Phase 3 TEMSO , TOWER , and the TEMSO extension showed that Aubagio stabilized disability progression in these patients over nearly a decade. Other presentations homed in on Aubagio’s ability to slow brain tissue loss and improve cognitive outcomes. Finally, Sanofi Genzyme shared initial data on its investigational antibody GLD52. The treatment is an updated form of Lemtrada, which scientists believe gives rise to fewer and milder infusion-related reactions. Data from the Phase 1 study , so far indicated that this might indeed be the case, as no severe reactions occurred in the 44 progressive MS patients in the trial. For a complete list of Sanofi Genzyme's presentations at the meeting, visit this link.

Mavenclad reduced multiple sclerosis relapses by 79 percent and prevented the development of additional inflammatory lesions in 84 percent of patients with high disease activity, according to presentations Merck KGaA will make in Paris next week. The company will share a host of new data at the 7th Joint ECTRIMS-ACTRIMS…

TG Therapeutics’ ublituximab nearly eradicated a type of immune B-cell believed to be involved in multiple sclerosis, according to a Phase 2 clinical trial. The result was that none of the patients had a relapse during the first six months of the trial, which is continuing, researchers said. In addition, ublituximab reduced the brain and spinal cord lesions of the relapsing MS patients involved in the trial and prevented new ones from forming. The company will present the interim trial results in three poster presentations at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25-28. Meanwhile, researchers will continue to study the effectiveness of ublituximab, a B-cell-depleting antibody, versus a placebo, for another six months. The trial is being held at several U.S. medical facilities. Participants receive two initial infusions of ublituximab or a placebo on day 1 and 15 during the first 28 days. After this initial period, those in the placebo-group are also given ublituximab and followed for 52 weeks. A key trial finding was that over the initial 24 weeks of the trial, the treatment nearly wiped out a type of B-cell known as CD20 that scientists believe is involved in the development of MS. Only 1 percent of the B-cells remained after a month. While helpful immune T-cell numbers dropped slightly after the first ublituximab infusion, they bounced back quickly. Researchers also reported a reduction in patients' magnetic resonance imaging (MRI) lesions, with no new inflammatory lesions appearing during the six months. So far, none of the trial participants has had a serious adverse event. Most of the adverse events were mild or moderate and related to the infusions. The trial also demonstrated that speeding up infusions did not increase infusion-related reactions. The speed-up results indicated that — if proven effective and safe — ublituximab will be more convenient for patients than B-cell-depleting drugs that require infusions stretching over several hours.

Genentech will present a host of new information on its multiple sclerosis treatment Ocrevus and lessons its scientists have learned about the disease at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25–28. The presentations will offer new insights into the therapy's mechanisms, safety and effectiveness in people with the primary progressive and relapsing forms of MS. They will also look at new ways to track MS, including additional biomarker possibilities. MS experts say the joint meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) is one of the largest global congregations of scientists working on the disease. The information Genentech plans to present will demonstrate "the commitment of our scientists and research partners to advance understanding of MS progression through ongoing analyses of the Ocrevus Phase 3 clinical trials,” Dr. Sandra Horning, the company's chief medical officer and head of its Global Product Development arm, said in a press release. Genentech, which is part of the Roche group, said the 18 presentations will represent the largest body of evidence ever presented on Ocrevus. The discussions will reinforce the therapy's favorable benefit-risk profile, Genentech added. Two presentations will cover new ways that doctors can look for signs of disease activity that can lead to disability. One yardstick is called progression independent of relapse activity, or PIRA. Another is tracking slowly evolving lesions. Genentech researchers came up with the approaches when they analyzed a subgroup of patients in the OPERA I and OPERA II Phase 3 clincal trials, whose aim was to evaluate Ocrevus as a treatment for relapsing MS. The patients' disease progressed even though they had no relapses, researchers said. The team will also discuss how Ocrevus affected these patients' disease. Another presentation will cover long-term follow-up data from an extension of the ORATORIO Phase 3 clinical trial (NCT01194570), which dealt with Ocrevus' ability to treat primary progressive MS. It will   look at how well Ocrevus slowed the progression of patients' disability. Updated information on Ocrevus’ safety —  based on open-label extension studies — will be another component of the presentations. So far, researchers have detected no new safety issues. Genentech will also discuss a new way of using conventional magnetic resonance imaging (MRI) to identify and track slowly evolving lesions. The company's scientists think that tracking the lesions may be a good way to measure chronic disease activity. This would contrast with tracking ordinary MS lesions, which are biomarkers of acute — as opposed to chronic — disease activity. In addition to "two new potential markers of underlying disease activity and their impact on disease progression, we hope to bring new tools to the MS community to better understand and manage the disease,” Horning said. One tool, which Genentech has begun testing in clinical trials, is gathering patient information with sensors connected to a smartphone. Researchers are comparing the information obtained in the FLOODLIGHT study with what physicians record during patient visits. The research team believes the FLOODLIGHT method may be be able to detect subtle changes better. This could make it a better predictor of disease activity and long-term patient outcomes. In addition to the presentations, Genentech will sponsor two symposia at the meeting that will discuss how MS progresses, features of the chronic version of the disease, and the link between inflammation and the progression of MS. The U.S. Food and Drug Administration approved Ocrevus in March 2017.  

If you have MS, you’ve probably used a specialty drug. My first was Avonex, which I began to use about 1998. Several others followed. There’s no formal definition of a specialty drug, but these therapies have several things in common. First, they’re expensive. According to the vice president in…

Nimbus Therapeutics and Celgene have agreed to work together to identify potential therapeutic compounds that can specifically target Tyk2 and STING — two proteins involved in inflammation and innate immune response. This strategic collaboration can open new therapeutic avenues for the treatment of multiple sclerosis (MS) and several autoimmune disorders. Nimbus, headquartered in Cambridge, Massachusetts, applies chemical computational analysis to identify and develop new compounds with potential for therapeutic use in a range of diseases. Two Nimbus immunology programs are already covered under the newly established agreement: one developing inhibitors of Tyk2 and antagonists of STING protein. Tyk2, or tyrosine kinase 2, mediates the signaling of several pro-inflammatory proteins, including interleukin (IL)-23, IL-12 and type-I interferons. Inhibiting this enzyme can stop signals from passing through. This can potentially impair inflammatory response. STING, or stimulator of interferon genes, is an important activator of immune responses. As such, finding ways to block its activity can help prevent autoimmunity and reestablish immune response balance. Under their accord, Nimbus will control the program's research and development; Celgene will have the option to acquire each program covered by the alliance.

Lemtrada Prevented Progression of Multiple Sclerosis for Five Years, Study Shows Full disclosure: I’m being treated with Lemtrada, so any news about it lights up my radar like a Christmas tree. I’m 10 months post-round 1 and am doing well — and this news looks like it’s…

The U.S. Food and Drug Administration has approved both lower and higher doses of Mylan’s generic versions of Copaxone (glatiramer acetate) for relapsing multiple sclerosis. It is the first time the agency has authorized a higher-dose generic. Generic versions of the lower dose of 20 mg/mL — intended for…

Fast Forward, a non-profit subsidiary of the National Multiple Sclerosis Society, will give financial support to TG Therapeutics to advance TGR-1202 (umbralisib) into preclinical testing as a potential oral therapy for progressive forms of multiple sclerosis. The support, whose value was not specified, is part of a Sponsored Research Agreement between Fast Forward and the company. Research work will be led by Lawrence Steinman, MD, a professor of pediatrics, neurology, and neurological sciences at Stanford University. TGR-1202 is an orally administrated inhibitor that blocks a signaling enzyme called PI3K delta. Immune cells such as B-cells have high levels of this enzyme, which is thought to be important for cell proliferation and survival. "We look forward to evaluating umbralisib [TGR-1202]'s effect on our preclinical progressive MS models in hopes to move umbralisib closer to clinical development in MS," Steinman said. The approval of Ocrevus (ocrelizumab), by Genentech, to treat primary progressive and relapsing multiple sclerosis underscored the potential of B-cell-targeted therapies for MS patients. As a result, investigative drugs that also aim to bolster B-cell survival or activity, such as those being developed by TG Therapeutics, are an attractive approach to potentially treating patients. Another potential treatment by the company — an engineered antibody, TG-1101 — targets a specific sequence on the CD20 protein found on immune B-cells. This infusion therapy is now in two Phase 3 clinical studies for relapsing multiple sclerosis, ULTIMATE I and ULTIMATE II. Both are currently enrolling patients at sites in Kentucky, Tennessee, and New York.

A five-year study demonstrated that Sanofi-Genzyme’s Lemtrada (alemtuzumab) provides long-term benefits for relapsing-remitting multiple sclerosis patients, reducing relapse rates and preventing the progression of the disease. Importantly, most patients required only the standard two-phase treatment course. Few needed additional courses because of relapse or new brain lesions. The study,…

Do you ever stop and ponder the value of MS drugs? I’m not talking about if they work and the ways they improve our lives. I’m thinking of the COST of them and what their pricing means to investors. I get several market analysis reports on the pharmaceutical industry,…

Relapsing-remitting multiple sclerosis (RRMS) patients accurately report the use of the RebiSmart autoinjector to their neurologists, a questionnaire-based study has found. The Phase 4 noninterventional CORE study also suggests that being knowledgeable about RebiSmart is a key factor in improving usage in younger patients and those with lower disability levels.