FDA Approves Plegridy as Intramuscular Injection for Relapsing MS 4.5 (11)
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 developer, treatment given via intramuscular injection is as effective as the subcutaneous (under-the-skin) injection formulation long in use, but lowers the likelihood of injection site reactions.
This new formulation also was recently approved by the European Commission.
“Plegridy is a proven, effective therapy for relapsing MS, and this approval gives new and current MS patients a different delivery method that has the potential to significantly reduce injection site reactions,” Maha Radhakrishnan, MD, Biogen’s chief medical officer, said in
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The recently launched BRAINTEASER project focuses on the use of artificial intelligence (AI) technology to improve the care of patients with multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS).
An initiative of a European consortium, BRAINTEASER could benefit patients, caregivers, and clinicians by enhancing the ability to predict, detect, and manage factors that contribute to disease progression.
“Through a simple system of wearable sensors and apps we intend to bring the advantages of artificial intelligence directly to the patient, by integrating models for short and long-term risk prediction, clinical decision aid and prevention,” Barbara Di Camillo, PhD, BRAINTEASER scientific and technical manager, said in a press release.
CHMP Favors Kesimpta for Adults With Relapsing MS in Europe 5 (8)
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 opinions by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which issued the recommendation.
“The positive CHMP opinion for Kesimpta underscores its potential to provide people living with [relapsing] MS in Europe with a new treatment that combines powerful efficacy with a favorable safety profile and can be taken at home,” Marie-France Tschudin, president of Novartis Pharmaceuticals, Kesimpta’s developer, said in a press release.
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Teams of scientists at the University of Toronto are sharing a nearly CA$21 million (about $16.36 million) award into research that might lead to self-repair treatments for multiple sclerosis (MS) and other neurological disorders, the university announced in a press release.
Eleven teams at the university and its partner hospitals will share the three-year grant from Medicine by Design, a University of Toronto research initiative focused on advancing regenerative medicine and cell therapy through interdisciplinary research.
Freda Miller, PhD, a neuroscientist who heads one these teams, will investigate the use of stem cells to promote the repair of myelin and muscle.
Rituximab, an approved treatment for certain blood cancers, works to deplete B-cells a type of immune cell known to drive inflammation in MS by targeting a protein on their surface called CD20. Investigational for MS, it has been tested in clinical trials, and is often used off-label to treat patients.
Data from a 48-week Phase 2 study (NCT00097188) in RRMS patients showed that rituximab suppressed their inflammatory disease activity. Other studies have also shown that rituximab is a safe and effective treatment option, with a low discontinuation rate.
But data are limited concerning the effects of stopping the therapy or dropping annual doses below 1,000 mg.