Drug approval

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,…

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 —…

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.

Banner Life Sciences announced that Bafiertam (monomethyl fumarate) will become available to adults with relapsing forms of multiple sclerosis (MS) in the United States beginning in September. The U.S. Food and Drug Administration (FDA) approved Bafiertam in April as a bioequivalent to Biogen’s Tecfidera…

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…

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…

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 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…

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…

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,…

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…

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 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…

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…

Vumerity Approved in US as Treatment for RRMS and Active SPMS By my count, Vumerity is the 18th disease-modifying therapy (DMT) that the U.S. Food and Drug Administration (FDA) has approved for multiple sclerosis (MS). It’s one of very few approved for secondary progressive MS (SPMS). I find…

The U.S. Food and Drug Administration (FDA) has approved Vumerity (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease (SPMS). Vumerity (previously known as ALKS 8700) was developed by Alkermes…

The U.S. Food and Drug Administration (FDA) has approved the use of Botox (onabotulinumtoxinA), marketed by Allergan, for the treatment of children ages 2 to 17 with upper limb muscle stiffness or spasticity, a common symptom in children with…