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.
(ofatumumab)
Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with RMS. It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously
1,3. Initial doses of Kesimpta are given at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional. As shown in preclinical studies, Kesimpta is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion
8. The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen
(ofatumumab)
Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with RMS. It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously
1,3. Initial doses of Kesimpta are given at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional. As shown in preclinical studies, Kesimpta is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion
8. The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen
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IMAGE: Signature of RENACER bylaws. From left to right and from top to bottom: Manuel Valiente (CNIO), Eva Ortega-Paíno (CNIO), Pilar Nicolás (ISCIII), Ángel Pérez (12 de Octubre Hospital), Elena Martínez. view more
Credit: CNIO
Last January 25th, the bylaws of the National Brain Metastasis Network (or RENACER, its acronym in Spanish) were signed and the network s first meeting was held. To date, 11 Spanish hospitals have joined the network to create a collection of human samples to further research into brain metastases, to improve both their diagnosis and treatment. Through this project, initiated and coordinated by the Brain Metastasis Group and the Biobank of the Spanish National Cancer Research Centre (CNIO), samples from the member hospitals will be collected and stored.
Search jobs 18-Jan-2021 Guardant Health and Vall d’Hebron Institute of Oncology Announce Partnership to Establish First Guardant-Based Liquid Biopsy Testing Service in Europe
BARCELONA, Spain & REDWOOD CITY, Calif. (BUSINESS WIRE) Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and Vall d’Hebron Institute of Oncology (VHIO), one of Europe’s leading cancer research organizations, have agreed to enter into a partnership to establish in-house liquid biopsy testing services, using Guardant Health’s industry-leading proprietary digital sequencing platform, at VHIO’s facility in Barcelona, Spain.
The service is expected to become operational in 2021 and will be available for clinical research and clinical care starting with private patients, followed by expansion into the public healthcare system over time.