Drug approval

The European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) who have active disease based on clinical or imaging features. The EC decision follows a positive opinion issued in March by the European Committee for Medicinal Products for Human Use (CHMP).

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Helius Medical Technologies’ portable neuromodulation stimulator (PoNS) for the treatment of walking impairments in multiple sclerosis (MS) patients. The device, which is meant to be used…

The U.S. Food and Drug Administration (FDA) has given final approval to Banner Life Sciences’ Bafiertam (monomethyl fumarate), a bioequivalent alternative to Biogen’s Tecfidera (dimethyl fumarate) to treat people with relapsing…

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted applications from Genentech to shorten the infusion time for Ocrevus, an approved treatment for multiple sclerosis. If approved, the time to administer Ocrevus will be shortened to a two-hour session, instead…

After being rejected twice in the last four years, Fampyra (fampridine; marketed as Ampyra in the U.S.) is now being recommended by the Scottish Medicines Consortium (SMC) for use in the country’s National Health System (NHS) to treat walking disabilities in adults with multiple sclerosis (MS). Scotland…

Zeposia’s recent approval in the U.S. is exciting news for all in the MS community. Unfortunately, we will need to table that excitement a bit longer. Despite its approval, the treatment’s commercial distribution will be delayed by the COVID-19 pandemic. I am confident, however, that it will be…

EHP-101, a cannabidiol-derived investigational therapy being developed by Emerald Health Pharmaceuticals (EHP) to treat multiple sclerosis (MS), is not a controlled substance in Canada, the company announced. The active ingredient in EHP-101 is a derivative of cannabidiol, abbreviated CBD. This is one of the most well-known active compounds in…

The Committee for Medicinal Products for Human Use (CHMP) has recommended Zeposia (ozanimod) oral capsules to be approved in the European Union (EU) to treat adults with active relapsing-remitting multiple sclerosis (RRMS). Opinions released by CHMP, an arm of the European Medicines Agency (EMA), are generally accepted by the European Commission,…

ANI Pharmaceuticals is asking the U.S. Food and Drug Administration (FDA) for the right to reintroduce in the U.S. market its Cortrophin Gel (repository corticotropin injection, 80 U/ml) to treat acute exacerbations in multiple sclerosis (MS) and other diseases. Currently, the only repository corticotropin injection available in…

The U.S. Food and Drug Administration (FDA) has approved Zeposia (ozanimod) oral capsules to treat adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS),  active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS). Due to the COVID-19 pandemic, however, when it will arrive in clinics…

Janssen has submitted an application to the U.S. Food and Drug Administration (FDA) asking for ponesimod to be approved as an oral treatment for adults with relapsing multiple sclerosis (MS). Ponesimod, formerly ACT-128800, is an experimental treatment that targets the protein sphingosine-1-phosphate…

Ponesimod may soon be a new oral therapy for people with relapsing multiple sclerosis (MS) in Europe, and a filing for its approval in the U.S. is likely within weeks. Janssen Pharmaceuticals, its developer, submitted an application to the European Medicines Agency (EMA) in early March, a first ponesimod filing…

By the end of this month, another disease-modifying therapy (DMT) for multiple sclerosis may be available in the U.S. Ozanimod is an investigational daily pill for the treatment of relapsing MS. The Food and Drug Administration is expected to decide…

Health Canada has approved Novartis‘s Mayzent (siponimod) for the treatment of adults with active secondary progressive multiple sclerosis (SPMS) to delay the progression of physical disability. Active disease is determined either by the presence of relapses or magnetic resonance imaging features characteristic of inflammatory activity. Multiple sclerosis (MS)…

Janssen has submitted an application to the European Medicines Agency (EMA) asking that ponesimod be approved as an oral treatment for adults with relapsing multiple sclerosis (MS) in the European Union. Ponesimod (formerly ACT-128800) is an experimental treatment that targets the sphingosine-1-phosphate receptor…

Using a patient-friendly autoinjector pen to take monthly doses of ofatumumab — an investigational B-cell therapy for relapsing multiple sclerosis (MS) — is bioequivalent to delivering it via a prefilled syringe, and would allow self-administration of the treatment at home, a study shows. Equal effects…

In this column, I’ll be highlighting some of the research presented at this year’s Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held last week in West Palm Beach, Florida. #ACTRIMS2020 — Remyelination in Adult Animal Brains Possible via Cell Transplant, Study Says You’ll need…

Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will review Novartis‘ applications seeking regulatory approval of ofatumumab, an investigational B-cell therapy for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Novartis’ applications for ofatumumab — which has the…

  The U.S. Food and Drug Administration (FDA) has granted approval to Flowonix Medical’s Prometra II Programmable Pump System for use with intrathecal baclofen for the treatment of spasticity across numerous conditions, including multiple sclerosis. Intrathecal baclofen — sold as Gablofen by Piramal, Lioresal by…

The experimental BTK inhibitor SAR442168 showed an acceptable safety profile and met its primary endpoint — a significant reduction in the number of new lesions visible on a brain imaging scan — in a Phase 2 trial in people with multiple sclerosis (MS), study results show. SAR442168,…

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for QyScore, a cloud-based imaging software for the automated quantification of key magnetic resonance imaging (MRI) markers of central nervous system (CNS) disease. MRI is an important tool for diagnosing multiple sclerosis and other CNS disorders. By…

EyeStat, a portable device to measure blink reflex, has been cleared for use by the U.S. Food and Drug Administration (FDA). On the heels of promising results for assessing brain injury, the manufacturer, Blinktbi, plans to test if the device can be used for the early detection…

Mayzent Helps Regulate the Immune System in SPMS, Study Shows Mayzent (siponimod) is one of several disease-modifying treatments that target specific T-cells and B-cells involved in damage to the myelin that protects our nerves. This study reports a significant reduction in these rogue cells within a year of starting…

The National Institute for Health Care and Excellence (NICE) in the U.K. issued its final decision, approving the inclusion of Plegridy (peginterferon beta-1a) to treat relapsing-remitting multiple sclerosis (RRMS) in England within the National Health Service (NHS). This decision follows a cost-effectiveness review done in May 2018,…

The European Commission has approved Novartis‘s Mayzent (siponimod) as the first oral treatment for adults with active secondary progressive multiple sclerosis (SPMS). Active SPMS is defined by the presence of evident relapses or the detection of inflammatory activity in brain lesions on imaging scans. “As the only indicated oral therapy proven for…

Ocrevus (ocrelizumab) has been approved in Scotland as a treatment for early, inflammatory primary progressive multiple sclerosis (PPMS). The Scottish Medicines Consortium (SMC) has advised that Ocrevus can be prescribed by the National Health Service (NHS) for people with PPMS who have had symptoms for less than 15…

The U.S. Food and Drug Administration (FDA) approved three generic versions of Gilenya (fingolimod) for the treatment of adults with relapsing forms of multiple sclerosis (MS). A generic is a nearly identical, lower-priced version of an original brand medication. The three generic applications approved Thursday by the…

Immunoadsorption May Be Superior to Plasma Exchange in Treating Steroid-resistant Relapses in MS Steroids may be an effective treatment for multiple sclerosis relapses, but they have negative side effects. Many people report a metallic taste, while others find it hard to sleep. And long-term use can affect bone…

Novartis’s Mayzent (siponimod) has been approved by Australia’s Therapeutic Goods Administration (TGA) for the treatment of secondary progressive multiple sclerosis (SPMS), making it the first therapy to be approved for this use in Australia. SPMS is a form of MS that develops after the onset of…

The Committee for Medicinal Products for Human Use (CHMP) issued an opinion supporting Mayzent (siponimod) as an oral treatment specifically for adults with active secondary progressive multiple sclerosis (SPMS) in the European Union. Opinions released by CHMP, an arm of the European Medicines Agency (EMA), carry weight and are…