November 17, 2021 News by Marisa Wexler, MS Vumerity Approved for RRMS in European Union The oral medication Vumerity (diroximel fumarate) has been approved by the European Commission to treat adults with relapsing-remitting multiple sclerosis (RRMS). “This approval is a significant step forward in improving treatment adherence for people living with relapsing MS, which can make a meaningful difference on treatment…
September 20, 2021 News by Marisa Wexler, MS Vumerity Recommended for EU Approval as RRMS Treatment A committee of the European Medicines Agency is recommending that Vumerity (diroximel fumarate) be approved as an oral treatment for adults with relapsing-remitting multiple sclerosisĀ (RRMS) in the European Union. The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent…
September 8, 2020 News by Joana Carvalho, PhD Bafiertam, Oral Relapsing MS Therapy, Arrives in US Bafiertam (monomethyl fumarate), a bioequivalent of TecfideraĀ to treat relapsing forms of multiple sclerosis (MS), is now available to patients in the U.S. through a network of specialty pharmacies, Banner Life Sciences, the therapyās developer, announced. Banner previously stated that Bafiertam would arrive on the market…
July 20, 2020 News by Forest Ray PhD Bafiertam, for Adults With Relapsing MS, Available in US in September Banner Life Sciences announced thatĀ Bafiertam (monomethyl fumarate) will become available to adults with relapsing forms of multiple sclerosis (MS) in the United States beginning in September. The U.S. Food and Drug AdministrationĀ (FDA)Ā approved Bafiertam in April as a bioequivalent to BiogenāsĀ Tecfidera…
May 5, 2020 News by Steve Bryson, PhD FDA Approves Bafiertam, Tecfidera Bioequivalent, for Relapsing MS The U.S. Food and Drug Administration (FDA) has given final approval toĀ Banner Life Sciencesā Bafiertam (monomethyl fumarate),Ā a bioequivalent alternative to Biogenās Tecfidera (dimethyl fumarate) to treat people with relapsing…
July 25, 2019 News by Steve Bryson, PhD Tecfidera Up Against Bafiertam in Phase 1 Study of GI Tolerability A first healthy volunteer has enrolled in a randomized, double-blind Phase 1 study to compare the gastrointestinal (GI) tolerability and safety of oral Tecfidera to Bafiertam, an oralĀ bioequivalent in treating relapsing forms of multiple sclerosis (MS),Ā Banner Life Sciences…
January 4, 2019 News by Alberto Molano, PhD Bafiertam, a Bioequivalent of Tecfidera, Receives Tentative OK from FDA for RRMS Banner Life SciencesĀ has received tentative approval from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for Bafiertam (monomethyl fumarate), a novel bioequivalent of Biogenās Tecfidera (dimethyl fumarate) for the treatment of relapsing-remitting multiple sclerosis (RRMS). Final approval is expected no later than…
November 29, 2017 News by Alice MelĆ£o, MSc Alkermes, Biogen Partnering on Therapy for Relapsing Forms of Multiple Sclerosis AlkermesĀ and BiogenĀ have begun working together on a compound known asĀ ALKS 8700Ā as a potential treatment for relapsing forms of multiple sclerosis. Under the agreement, Alkermes will be responsible for obtaining regulatory approval of the drug, while Biogen will handle its marketing. ALKS is taken orally. The body quickly transforms it into a compound known as monomethyl fumarate that can counter MS. Aikermes designed it to have better features thanĀ Tecfidera (dimethyl fumarate)Ā ā in particular, fewer gastrointestinal side effects. The partnership gives Biogen worldwide marketing rights to ALKS 8700. Alkermes will receive a royalty on global sales. Aikermes is evaluating ALKS 8700's safety and effectiveness in what it has dubbed the EVOLVE-MS clinical trial program. It includes two Phase 3 trials that are comparing ALKS 8700 with Tecfidera in patients with relapsing-remitting MS, or RRMS. Preliminary results of the EVOLVE-MS-1 trial, which involved 580 patients, showed few gastrointestinal side effects from ALKS 8700. The most common adverse events in the first month of treatment were flushing, diarrhea, and a rash known as pruritus. Aikermes discussed the treatments safety, and patients' ability to tolerate it, at the 7th Joint ECTRIMS-ACTRIMS MeetingĀ in Paris in October. The company is still recruiting participantsĀ for a second trial that will compare ALKS 8700 and Tecfidera's effect on the gastrointestinal system. The EVOLVE-MS-2 study will Ā be conducted at locations in several U.S. states and six sites in Poland. Alkermes expects to release initial findings from the trial in the first half of 2018. Ā
November 1, 2017 News by Alice MelĆ£o, MSc #MSParis2017 ā EVOLVE-MS-1 Interim Trial Data Shows Alkermes Therapy Safe for Treating Relapsing MS Preliminary data from the Phase 3 EVOLVE-MS-1 trial shows thatĀ ALKS 8700Ā ā an investigative therapy developed byĀ AlkermesĀ to treat relapsing forms of multiple sclerosis ā has a good safety and tolerability profile. ALKS 8700 is an oral compound. Once inside the body, it is rapidly transformed into the therapeutic compound monomethyl fumarate (MMF). Although similar, this drug candidate was designed to offer features different than those achieved with the commercially available Tecfidera (dimethyl fumarate). Alkermes is currently assessing the safety and efficacy of ALKS 8700 in the EVOLVE-MS program, which includes two Phase 3 clinical trials in patients with relapsing-remitting MS. The EVOLVE-MS-1 is a two-year study being conducted in 107 U.S. and European research sites. It will evaluate the long-term safety of ALKS 8700 in some 930 RRMS patients. Interim data collected during the first month of treating 580 participants showed low incidence of GI adverse events, with no reports of serious events. The most common adverse side effects associated with the treatment were flushing, pruritus and diarrhea. Alkermes, which is based in Ireland, said additional results from the initial three months of treatment further supported the positive safety data of ALKS 8700, with only 2.3 percent of patients reporting serious adverse events and 3.7 percent having to stop treatment. The EVOLVE-MS-2 trial, being conducted at 48 U.S. sites, will compare the safety and efficacy of ALKS 8700 versus Tecfidera in RRMS patients. The study is still recruiting participants. Recent data of EVOLVE-MS-2 was also subject of a poster presentation at the ECTRIMS-ACTRIMS Meeting.
October 20, 2017 News by Patricia Silva, PhD #MSParis2017 – Alkermes to Give Updates on ALKS 8700 Studies at ECTRIMS-ACTRIMS Meeting Alkermes will showcase its work in developing a treatment that harnesses the effect of Tecfidera (dimethyl fumarate) for relapsing multiple sclerosis (MS), while lowering the risk of stomach problems at the 7th Joint ECTRIMS-ACTRIMS Meeting this month in Paris. The investigational drug, ALKS 8700, uses the same mechanism of action as Tecfidera. By building the molecule in a different way, however, the company expects it will show better tolerability. Once in the body, dimethyl fumarate turns into monomethyl fumarate (MMF), the molecule that actually impacts MS disease processes. But before giving rise to MMF,Ā dimethyl can cause side effects in users, particularly gastrointestinal. In fact, stomach problem were what causedĀ people in Tecfidera Phase 3 trials to stop the treatment. Alkermes uses a so-called prodrug approach to try to overcome this problem. By attaching a different compound to MMF āĀ which breaks away from the molecule once in the body ā Ā it is possible to deliver MMF with lesser gastrointestinal side effects, Phase 1 study data indicate. At the meeting, the company will present two posters on two clinical trials exploring ALKS 8700 in patients with relapsing-remitting MS. The first presentation, will describe a Phase 3 trial that aims to compare ALKS 8700 to Tecfidera in about 420 patients. The trial is primarily concerned with the drugās safety, and will measure the occurrence and impact of gastrointestinal side effects in the two treatment groups. The presentation will only include descriptions of patients characteristics and study design, as outcomes are yet to be analyzed. Patients who complete the Phase 3 trial will be eligible to continue in an ongoing open-label, long-term safety study, called EVOLVE-MS-1, covered in the companyās second presentation. By March 3, 2017, the study had enrolled 543 patients. In addition to describing patient characteristics, researchers will present the rates of discontinuation caused by gastrointestinal adverse events within one month of starting the treatment.
March 20, 2017 News by Patricia Silva, PhD Alkermes Begins Phase 3 Study of ALKS 8700 as Relapsing MS Treatment AlkermesĀ has started a Phase 3 clinical trial evaluating ALKS 8700, the oral monomethyl fumarate (MMF) prodrug it is developing for the treatment of relapsing forms of multiple sclerosis (MS). The multicenter, double-blind, active-controlled trial (NCT02634307) will examine whether the gastrointestinal tract can tolerate ALKS 8700 better thanĀ Tecfidera…
December 18, 2015 News by Patricia Silva, PhD New MS Drug Therapy Based on Monomethyl Fumarate Moving Along in Testing Alkermes plc, a biopharmaceutical company focused on therapies for the treatment of central nervous system (CNS) disorders, announced that it has successfully met its 2015 goals for their product and late-stage pipeline drug portfolio, including ALKS 8700, a monomethyl fumarate (MMF) drug candidate for the treatment of multiple sclerosis…