The U.S. Food and Drug Administration (FDA) has agreed to review TG Therapeutics’ application seeking the approval of ublituximab as a treatment for people with relapsing forms of multiple sclerosis. An FDA’s decision is expected on or before Sept. 28. The agency is not currently planning to hold an…
Drug approval
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…
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…
The injectable ACTH gel medication Cortrophin Gel (repository corticotropin injection), first introduced in the U.S. in the 1950s, will now be relaunched as a treatment for acute flare-ups in multiple sclerosis (MS) and other autoimmune conditions, following its approval by the U.S. Food and Drug Administration (FDA). In…
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…
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 sclerosis (RRMS) in the European Union. The opinion, from the agency’s Committee for Medicinal Products for Human Use (CHMP), will now be sent…
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 expanded the label for Botox (onabotulinumtoxinA) in adults for the treatment of upper limb spasticity — a common symptom of multiple sclerosis (MS) — to include eight more muscles. The new approval will allow Botox to be used to treat…
The European Commission (EC) has approved Aubagio (teriflunomide) for the treatment of children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS). Aubagio, approved for adults with RRMS since 2013, is now the first oral therapy available as a first-line treatment for pediatric patients in the European…
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…
Foralumab, an investigational anti-CD3 antibody that is administered via a nasal spray, has been given for the first time to a person with secondary progressive multiple sclerosis (SPMS). It was administered under an Individual Patient Expanded Access Program, which earned approval from the U.S. Food and Drug Administration in…
The European Commission has approved Ponvory (ponesimod) to treat adults with relapsing forms of multiple sclerosis (MS) and active disease, as defined by clinical or imaging features. The approval, which follows a recommendation from the Committee for Medicinal Products for Human Use in March, covers clinically isolated…
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…
Tecfidera (dimethyl fumarate) was given the green light by health regulators in China to treat people with relapsing multiple sclerosis (MS) — clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. The National Medical Products Administration’s (NMPA) decision came through a priority review of clinical trial data for Tecfidera,…
The European Commission (EC) has approved a new method to administer Tysabri (natalizumab) as a treatment for people with relapsing-remitting multiple sclerosis (RRMS). This new delivery route involves a subcutaneous injection in which Tysabri is injected under the skin. Compared with the previously approved intravenous (into the bloodstream) formulation,…
The European Commission has approved Novartis’ Kesimpta (ofatumumab) as the first self-administered, at-home B-cell-targeting therapy for adults with relapsing forms of multiple sclerosis (MS) and active disease. Active disease in these forms, which include clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS),…
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…
A branch of the European Medicines Agency has recommended that Ponvory (ponesimod) be approved to treat relapsing forms of multiple sclerosis (MS) in adults with active disease. This positive opinion from agency’s Committee for Medicinal Products for Human Use (CHMP) covers clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary…
Health Canada has approved Kesimpta (ofatumumab) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) who have active disease, as defined by clinical and imaging features. In contrast with other B-cell-targeting therapies used in MS, patients can self-administer a precise dose of Kesimpta at home using the Sensoready…
The U.S. Food and Drug Administration (FDA) has approved Ponvory (ponesimod) as an oral treatment for adults with relapsing forms of multiple sclerosis (MS). The approval covers clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). The treatment is taken as a…
The Scottish Medicines Consortium (SMC) has approved Zeposia (ozanimod) for the treatment of active relapsing-remitting multiple sclerosis (RRMS). Zeposia is sold as a tablet, to be taken by mouth once daily. The SMC has recommended that Zeposia be prescribed for people with RRMS who experience relapses or have evidence of…
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…
The National Institute for Health and Care Excellence (NICE) does not recommend Zeposia (ozanimod) be available at low or no cost through the National Health Service (NHS) to treat adults with active relapsing-remitting multiple sclerosis (RRMS) living in England and Wales. In a recent draft recommendation, NICE stated that …
The European Commission (EC) has approved a new, intramuscular formulation of Plegridy (peginterferon beta-1a) to treat people with relapsing-remitting multiple sclerosis (RRMS). This new mode of administration — in which Plegridy is directly injected into the muscle, rather than under the skin (subcutaneously) — does…
The U.S. Food and Drug Administration has approved a shorter infusion time of Ocrevus (ocrelizumab) for treating relapsing or primary progressive multiple sclerosis (MS). Infusion refers to the slow delivery of a therapy directly into the bloodstream over a period of time. The decision shortens the twice-yearly infusion…
Mayzent (siponimod) has become the first oral medication to be approved for people with active secondary progressive multiple sclerosis (SPMS) in England and Wales. Following this decision by England’s National Institute for Health and Care Excellence (NICE) — which reversed its opinion announced in June — the…
The Scottish Medicines Consortium (SMC) has approved Mayzent (siponimod) for the treatment of active secondary progressive multiple sclerosis (SPMS) in Scotland. Mayzent, developed by Novartis, is a tablet taken once daily to counter a person’s disability progression. SPMS gradually develops from relapsing-remitting MS, and is…
Health Canada has approved Zeposia (ozanimod), an oral daily treatment for people with relapsing-remitting multiple sclerosis (RRMS) in the country. Approval does not assure that Zeposia will be available to Canadian patients at no or low cost, as publicly funded prescription plans are largely administered by each…
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…
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…