March 11, 2024 News by Lindsey Shapiro, PhD FDA declines to approve GA Depot as treatment for relapsing MS The U.S. Food and Drug Administration (FDA) has decided not to approve an application seeking clearance of GA Depot ā a long-acting formulation of glatiramer acetate ā for the treatment of relapsing forms of multiple sclerosis (MS). Importantly, this is not a rejection of the application for the…
September 21, 2023 News by Patricia Inacio, PhD FDA clears first clinical study of investigational therapy LPX-TI641 Lapix Therapeutics is launching a Phase 1 clinical trial to evaluate LPX-TI641, its investigational treatment for autoimmune diseases such as multiple sclerosis (MS), in healthy individuals. The first-in-human trial (NCT05853835) is expected to begin dosing later this year. It follows the recent clearance of an investigational new…
August 8, 2023 News by Lindsey Shapiro, PhD FDA decision on GA Depot for relapsing MS expected March 2024 The U.S. Food and Drug Administration (FDA) has agreed to review Viatris and Mapi Pharma‘s application seeking approval of GA Depot for the treatment of relapsing forms of multiple sclerosis (MS). The medication is a long-acting formulation of glatiramer acetate, the active ingredient in the approved…
August 22, 2022 News by Marta Figueiredo, PhD Oral Therapy TRE-515 Wins Orphan Drug Status for Optic Neuritis in US The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Trethera Corporationās experimental oral therapy TRE-515 for demyelinating optic neuritis, an eye condition that may progress to multiple sclerosis (MS) or occur during the disease course. The first-in-class therapy is expected to lessen the inflammation…
July 27, 2022 News by Margarida Maia, PhD Natalizumab, Biosimilar of Tysabri for Relapsing MS, Under FDA Review The U.S. Food and Drug Administration (FDA) has agreed to review an application requesting thatĀ Polpharma Biologics‘ natalizumab, a biosimilar of Tysabri, be approved to treat relapsing forms ofĀ multiple sclerosis (MS). Its intended U.S. use is for the same indications as the approved name-brand medicine, coveringĀ clinically isolated…
July 1, 2022 News by Lindsey Shapiro, PhD Phase 3 Tolebrutinib Trials Pause US Enrollment Over Safety Concerns The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on Phase 3 trials testing the investigational therapy tolebrutinib in people with multiple sclerosis (MS) and myasthenia gravis based on reports of medication-induced liver injury. Under the clinical hold, new enrollment at U.S. sites…
June 1, 2022 News by Marisa Wexler, MS FDA Decision on Ublituximab for Relapsing MS Pushed to Year’s End The U.S. Food and Drug Administration (FDA) is extending by three months its review ofĀ ublituximab, an experimental anti-CD20 antibody being developed by TG Therapeutics for relapsing forms of multiple sclerosis (MS). The FDA had agreed to review the company’s application requesting ublituximab’s approval late last year, and…
April 12, 2022 News by Marta Figueiredo, PhD 8 More SPMS Patients Cleared for Foralumab Nasal Spray Treatment Based on findings from the first two secondary progressive multiple sclerosis (SPMS) patients givenĀ foralumab nasal spray, an experimental therapy, the U.S. Food and Drug Administration (FDA) has approved starting treatment in up to eight other patients under a special access program. Those enrolled in this intermediate-size expanded access…
January 11, 2022 News by Lindsey Shapiro, PhD 2nd Patient to Get Foralumab Nasal Spray After Promising First Data Following promising data from the first participant in a special access program that’s testingĀ foralumabĀ nasal spray forĀ secondary progressive multiple sclerosis (SPMS), a second patient has been enrolled in the ongoing evaluation. The first patient in the study, by Tiziana Life Sciences, the nasal spray’s developer, was halfway through…
January 10, 2022 News by Marta Figueiredo, PhD FDA Expands MRI Compatibility With Spinal Stimulation for Pain The U.S. Food and Drug Administration (FDA) has approved Abbottās request to expand the magnetic resonance imaging (MRI) compatibility with its Proclaim XR spinal cord stimulation system with Octrode leads, which is used to manage chronic pain. The decision lifts previous restrictions for Octrode lead tip location and…
December 9, 2021 News by Patricia Inacio, PhD FDA Approves Lyvispah, Granular Form of Baclofen, to Treat Spasticity The U.S. Food and Drug Administration (FDA) has approved Lyvispah, a dissolvable granular formulation of baclofen, to treat spasticityĀ in people withĀ multiple sclerosis (MS). The strawberry-flavored formulation, developed byĀ Saol Therapeutics, is particularly suitable to ease flexor spasticity, the involuntary bending of the knees and hips toward the…
October 1, 2021 News by Steve Bryson, PhD Ublituximab, Potential Relapsing MS Therapy, Up for FDA Approval TG TherapeuticsĀ has applied to the U.S. Food and Drug Administration (FDA) for approval ofĀ ublituximab, the companyās investigational anti-CD20 monoclonal antibody therapy for relapsing forms of multiple sclerosis (RMS). Its application was based on data from the ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) Phase…
September 2, 2021 News by Somi Igbene, PhD FDA to Review ANI’s Request for Cortrophin Gel Use The U.S. Food and Drug Administration (FDA) has agreed to review ANI Pharmaceuticalsā supplemental new drug application for the approval of Cortrophin Gel to treat people with multiple sclerosis (MS) and other chronic inflammatory conditions, including rheumatoid arthritis. Purified Cortrophin Gel (repository corticotropin injection USP) is a purified…
June 15, 2021 News by Marisa Wexler, MS FDA Rejects Expansion of Aubagio for Pediatric MS The U.S. Food and Drug Administration (FDA) has rejected an application requesting the expansion of Aubagio (teriflunomide) for the treatment of children and adolescents, ages 10 to 17, with relapsing forms of multiple sclerosis (MS). “The FDA deemed the data submitted were not sufficient to obtain approval of…
April 30, 2021 News by Forest Ray PhD FDA Rejects Under-the-skin Tysabri for Relapsing MS The U.S. Food and Drug Administration (FDA) has rejected Biogen‘s request for approval of under-the-skin administration of TysabriĀ (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS). “This response from the FDA does not affect the intravenous administration of Tysabri, a well-established high-efficacy treatment with a…
March 29, 2021 News by Marisa Wexler, MS PoNS Device to Help Adults in Rehab for Walking Problems Gets FDA Approval The U.S. Food and Drug Administration (FDA) has authorized the use of a medical device called Portable Neuromodulation StimulatorĀ or PoNS as a short-term treatment for walking difficulties in people with multiple sclerosis (MS). PoNS, developed by Helius Medical Technologies, is a non-invasive medical device…
February 2, 2021 News by Marisa Wexler, MS FDA Approves Plegridy as Intramuscular Injection for Relapsing MS The U.S. Food and Drug Administration (FDA) has approved an intramuscular injectionĀ formulation of Plegridy (peginterferon beta-1a) to treat people with relapsing forms of multiple sclerosis (MS). This formulation, for injection directly into muscle, is what is typically used to deliver the flu shot. According to Biogen, Plegridy’s…
January 12, 2021 News by Marisa Wexler, MS Helius Provides More Information to FDA About PoNS Device Helius Medical Technologies has submitted its response to the U.S. Food and Drug Administration (FDA)’s request for more information about the company’s application for de novoĀ classification and clearance of its portable neuromodulation stimulator (PoNS) device to help treat walking difficulties in people…
November 3, 2020 News by Joana Carvalho, PhD InnoCare Cleared to Launch Phase 2 Trial to Test Orelabrutinib in RRMS Patients InnoCare Pharma is preparing to launch a Phase 2 trial to assess the safety and efficacy of orelabrutinib, its investigational Bruton tyrosine kinase inhibitor, in patients with relapsing-remitting multiple sclerosis (RRMS). The trial, which is expected to enroll approximately 160 patients, will be carried out in the U.S.
October 8, 2020 News by Sara Guariglia FDA Approves Lupin’s Generic Form of Tecfidera for MS Treatment Lupin‘s generic equivalent ofĀ Tecfidera has been approved by the U.S. Food and Drug Administration (FDA) for the treatment ofĀ multiple sclerosis (MS), the company announced in a press release. The therapy ā dimethyl fumarate delayed-release capsules ā is indicated for use in people withĀ clinically…
October 2, 2020 Columns by Ed Tobias Is the FDA Changing Course on Amalgam Dental Fillings and MS? For years, some people have warned of a possible connection between multiple sclerosis (MS) and the amalgam fillings many of us have in our teeth. The concern has been that these fillings contain mercury, which can be toxic, especially if they are removed. In large part, these concerns have…
October 2, 2020 News by Patricia Inacio, PhD MS Patients Should Avoid ‘Silver’ Tooth Fillings Due to Mercury, FDA Advises People with multiple sclerosis (MS) are among theĀ high-risk groups advised to avoid dental amalgams āĀ silver-colored fillings that are 50% mercury ā underĀ new recommendations issued by theĀ U.S. Food and Drug AdministrationĀ (FDA). Amalgams can be used by dentists to restore the structure and surfaces of teeth damaged by decay.
September 29, 2020 News by Joana Carvalho, PhD FDA Approves Generic of Tecfidera for Adults With Relapsing MS The U.S. Food and Drug Administration (FDA) has approved Ciplaās dimethyl fumarate capsules, a generic version of Biogenās Tecfidera, to treat adults with relapsing forms of multiple sclerosis (MS), the company announced in aĀ press release. This generic is packagedĀ as 120 mg or 240 mg…
September 25, 2020 News by Marisa Wexler, MS Anokion Planning Launch of Phase 1 Trial of Investigational MS Therapy ANK-700 The U.S. Food and Drug Administration (FDA) has accepted an investigational new drug application (IND) for ANK-700, a treatment candidate for multiple sclerosis (MS) that is being developed by the Swiss company Anokion. With this approval, Anokion can enter clinical testing and is planning to…
August 27, 2020 News by Marisa Wexler, MS MMJ International Holdings Manufacturing Cannabis-based Investigational Therapies for MS, Huntington’s MMJ International Holdings, in collaboration with a a specialty pharmaceutical solutions company, has begun manufacturing gelatin capsule medicines based on compounds found in cannabis, The company will investigate these in clinical trials as potential treatments forĀ multiple sclerosisĀ (MS) andĀ Huntingtonās disease. “As MMJ…
August 21, 2020 News by Marisa Wexler, MS FDA Approves Kesimpta, B-cell Targeting Therapy for Relapsing MS The U.S. Food and Drug Administration (FDA) has approved Novartis‘ Kesimpta (ofatumumab) as a self-administered treatment for adults with relapsing forms of multiple sclerosis (MS), meaning those withĀ clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). According to Novartis,…
August 20, 2020 News by Marisa Wexler, MS Mylan Launching Tecfidera Generic in US Mylan announced the launch of a first generic version of Tecfidera, a treatment for relapsing forms of multiple sclerosis (MS). The generic, now approved by the U.S. Food and Drug Administration (FDA), is the first generic of any MS treatment available in an oral solid ā…
August 11, 2020 News by InĆŖs Martins, PhD PoNS Device Under Review by FDA for Treating Walking Problems in MS Helius Medical Technologies has filed an application with the U.S. Food and Drug Administration (FDA) asking for de novo classification and clearance of itsĀ portable neuromodulation stimulator (PoNS) device for the treatment of walking deficits in multiple…
July 22, 2020 News by Joana Carvalho, PhD FDA Will Review Arbaclofen ER, Potential Oral Therapy for MS Spasticity The U.S. Food and Drug Administration (FDA) has agreed to review Ā Osmotica Pharmaceuticals‘ amended request for the approval of arbaclofen extended release (ER) tablets to treatĀ spasticity in people with multiple sclerosis (MS), the company announced.
July 2, 2020 News by Joana Carvalho, PhD Osmotica Amends NDA for Arbaclofen ER to Treat MS Spasticity Osmotica Pharmaceuticals has submitted an amended new drug application (NDA) to the U.S. Food and Drug Administration (FDA) requesting the approval of arbaclofen extended release (ER) tablets for the treatment of spasticityĀ in people with multiple sclerosis (MS). Arbaclofen ER (brand name…