Drug approval

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,…

Wise Therapeutics intends to seek U.S. Food and Drug Administration (FDA) approval of an anxiety management therapy for multiple sclerosis (MS), following the positive results of a clinical trial. In addition to conducting a proof-of-concept study in MS, Wise tested its digital technique — called attention bias…

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…

A branch of the European Medicines Agency (EMA) has recommended that Kesimpta (ofatumumab) be approved and made available to treat relapsing forms of multiple sclerosis (MS) in adults with active disease. A final decision from the European Commission (EC) is expected in about two months. Typically, the EC follows…

Clene Nanomedicine has been notified it will be given a U.S. patent, as requested, covering an invention using the company’s already patented gold nanocrystals for the treatment of multiple sclerosis (MS). A Notice of Allowance was received by the company. These notices are issued by the U.S. Patent…

Tonix Pharmaceuticals has filed a patent application with the World Intellectual Property Organization covering the use of TNX-1500 — its third-generation anti-CD154 antibody — for the prevention and treatment of autoimmune diseases, such as multiple sclerosis (MS), and organ transplant rejection. “There remains a significant need for new treatments with improved…

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…

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…

Eligible people with relapsing-remitting multiple sclerosis (RRMS) now have access to Mavenclad (cladribine) through seven provincial public drug plans in Canada, including the Régie de l’assurance maladie du Québec (RAMQ) and the Ontario Drug Benefit Exceptional Access Program. The oral treatment now is available through public drug programs…

The European Patent Office granted a patent for IMP761, Immutep‘s experimental antibody to be used in treating inflammatory and autoimmune conditions, including multiple sclerosis (MS). IMP761 targets a receptor found on the surface of immune system T-cells called lymphocyte-activation gene 3,…

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…

FDA Approves Kesimpta, B-cell Targeting Therapy for Relapsing MS The U.S. Food and Drug Administration’s approval of Kesimpta (ofatumumab) this month is a pretty big deal. Kesimpta is a once-a-month injectable disease-modifying therapy. There’s nothing else like it, because Kesimpta targets B-cells in the immune system. Until now, only…

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 with clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). According to Novartis,…

Ofatumumab Seen as Superior to Aubagio at Lowering Relapse Rates in Phase 3 Trials Ofatumumab is a cancer medication that’s awaiting approval by the U.S. Food and Drug Administration and the European Medicines Agency to treat MS patients. It’s delivered by injection once a month and aims to reduce…

The idea doesn’t seem very appealing to me, but a company is seeking approval from the U.S. Food and Drug Administration (FDA) for a product that might help people with MS walk better by mildly stimulating the tongue. The portable neuromodulation stimulator (PoNS) is a flat…

The U.S. Food and Drug Administration (FDA) has agreed to review  Osmotica Pharmaceuticals‘ amended request for the approval of arbaclofen extended release (ER) tablets to treat spasticity in people with multiple sclerosis (MS), the company announced.

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 spasticity in people with multiple sclerosis (MS). Arbaclofen ER (brand name…

By my unofficial count, disease-modifying therapy No. 19 has just become available to people with multiple sclerosis in the U.S. The U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) in late March. While pharmaceutical companies usually rush to make newly approved medications available to patients, with COVID-19 raging,…

The U.S. Food and Drug Administration (FDA) is extending its review of Novartis‘ ofatumumab, a possible self-administered injection therapy for relapsing multiple sclerosis (MS), the company announced. Originally expected in June, the FDA decision is now expected in September. “Novartis will continue to work with the FDA to…