Following negative Phase 3 trial results, Sanofi announced that it will not be pursuing approval of its experimental therapy tolebrutinib for primary progressive multiple sclerosis (PPMS). Meanwhile, a decision from the U.S. Food and Drug Administration (FDA) on tolebrutinib’s use in nonrelapsing secondary progressive MS (SPMS) is likely…
FDA
The U.S. Food and Drug Administration (FDA) has given tentative approval to Lupin’s Siponimod tablets, a bioequivalent version of Mayzent (siponimod), to treat people with relapsing forms of multiple sclerosis (MS). According to a company press release, the therapy is indicated for use in adults with clinically isolated syndrome,…
The U.S. Food and Drug Administration (FDA) granted fast track designation to EG110A, EG 427‘s DNA-based therapy to treat neurogenic detrusor overactivity (NDO) — a bladder disorder that can arise from spinal cord injury or neurodegenerative conditions such as multiple sclerosis (MS). The FDA gives fast track status to experimental…
Tiziana Life Sciences has received fast track designation from the U.S. Food and Drug Administration (FDA) for its intranasal foralumab to treat nonactive secondary progressive multiple sclerosis (SPMS). The FDA gives fast track status to experimental medicines that have the potential to fill unmet needs to treat serious…
The U.S Food and Drug Administration (FDA) authorized an investigational new drug application from Synaptogenix, clearing the company to launch a clinical trial to test whether its lead candidate bryostatin-1 can prevent cognitive decline in people with multiple sclerosis (MS). The open-label, Phase 1 clinical trial (NCT06190912),…
The U.S. Food and Drug Administration (FDA) has accepted SetPoint Medical, which is developing a nerve stimulator for people with relapsing-remitting multiple sclerosis (RRMS), into a pilot program designed to promote the development of new medical devices, the company said. The Total Product Life Cycle Advisory Program…
The U.S. Food and Drug Administration (FDA) has decided not to approve an application seeking clearance of GA Depot — a long-acting formulation of glatiramer acetate — for the treatment of relapsing forms of multiple sclerosis (MS). Importantly, this is not a rejection of the application for the…
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…
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…
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Trethera Corporation’s 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…
The U.S. Food and Drug Administration (FDA) has agreed to review an application requesting that Polpharma Biologics‘ natalizumab, a biosimilar of Tysabri, be approved to treat relapsing forms of multiple sclerosis (MS). Its intended U.S. use is for the same indications as the approved name-brand medicine, covering clinically isolated…
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…
The U.S. Food and Drug Administration (FDA) is extending by three months its review of 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…
Based on findings from the first two secondary progressive multiple sclerosis (SPMS) patients given 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…
Following promising data from the first participant in a special access program that’s testing foralumab nasal spray for 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…
The U.S. Food and Drug Administration (FDA) has approved Abbott’s 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…
The U.S. Food and Drug Administration (FDA) has approved Lyvispah, a dissolvable granular formulation of baclofen, to treat spasticity in people with multiple sclerosis (MS). The strawberry-flavored formulation, developed by Saol Therapeutics, is particularly suitable to ease flexor spasticity, the involuntary bending of the knees and hips toward the…
TG Therapeutics has applied to the U.S. Food and Drug Administration (FDA) for approval of ublituximab, the company’s 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…
The U.S. Food and Drug Administration (FDA) has agreed to review ANI Pharmaceuticals’ 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…
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…
The U.S. Food and Drug Administration (FDA) has rejected Biogen‘s request for approval of under-the-skin administration of Tysabri (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…
The U.S. Food and Drug Administration (FDA) has authorized the use of a medical device called Portable Neuromodulation Stimulator 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…
The U.S. Food and Drug Administration (FDA) has approved an intramuscular injection 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…
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 novo classification and clearance of its portable neuromodulation stimulator (PoNS) device to help treat walking difficulties in people…
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.
Lupin‘s generic equivalent of Tecfidera has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple sclerosis (MS), the company announced in a press release. The therapy — dimethyl fumarate delayed-release capsules — is indicated for use in people with clinically…
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…
People with multiple sclerosis (MS) are among the high-risk groups advised to avoid dental amalgams — silver-colored fillings that are 50% mercury — under new recommendations issued by the U.S. Food and Drug Administration (FDA). Amalgams can be used by dentists to restore the structure and surfaces of teeth damaged by decay.
The U.S. Food and Drug Administration (FDA) has approved Cipla’s dimethyl fumarate capsules, a generic version of Biogen’s Tecfidera, to treat adults with relapsing forms of multiple sclerosis (MS), the company announced in a press release. This generic is packaged as 120 mg or 240 mg…
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…