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CHMP Favors Kesimpta for Adults With Relapsing MS in Europe


CHMP Favors Kesimpta for Adults With Relapsing MS in Europe
5
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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. ....

United States , Sanofi Genzyme , Xavier Montalban , Hebron University Hospital , European Commission , Leiden University Medical Center , Novartis Pharmaceuticals , Society Of America , University Of Pittsburgh , European Medicines Agency , Sclerosis Centre Of Catalonia Cemcat At Vall , Committee For Medicinal Products Human Use , Medicinal Products , Human Use , France Tschudin , Multiple Sclerosis Centre , Molecular Pathology , Medical Microbiology , Infectious Diseases , Applied Biology , Instituto De Medicina Molecular , ஒன்றுபட்டது மாநிலங்களில் , ஐயேவியர் மோன்டல்பன் , ஹெப்ரான் பல்கலைக்கழகம் மருத்துவமனை , ஐரோப்பிய தரகு , நோவர்த்திச் மருந்துகள் ,

Investegate |NOVARTIS AG CHF0.50(REGD) Announcements | NOVARTIS AG CHF0.50(REGD): Novartis receives positive CHMP opinion for Kesimpta®* (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis


(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 ....

United States , France General , United Kingdom , City Of , Eric Althoff , Isabella Zinck , Thomas Hungerbuehler , Wallstroeme Ofatumumab , Xavier Montalban , Neuroimmunol Neuroinflamm , Samir Shah , Sloan Simpson , Meghan Odonnell , Antonio Ligi , Sclerosis International Federation , Americas Committee For Treatment , Novartis External Communications , Sclerosis Centre Of Catalonia Cemcat , Novartis Pharmaceuticals , Research In Multiple Sclerosis , Committee For Medicinal Products Human Use , Genmab Press , Hebron University Hospital , Drug Administration , European Commission , Novartis Us External Communications ,

Novartis receives positive CHMP opinion for Kesimpta®* (ofatumumab), a self-administered treatment for adult patients with relapsing multiple sclerosis


(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 ....

United States , France General , United Kingdom , City Of , Eric Althoff , Isabella Zinck , Thomas Hungerbuehler , Wallstroeme Ofatumumab , Xavier Montalban , Neuroimmunol Neuroinflamm , Samir Shah , Sloan Simpson , Meghan Odonnell , Antonio Ligi , Sclerosis International Federation , Americas Committee For Treatment , Novartis External Communications , Sclerosis Centre Of Catalonia Cemcat , Novartis Pharmaceuticals , Research In Multiple Sclerosis , Committee For Medicinal Products Human Use , Genmab Press , Hebron University Hospital , Drug Administration , European Commission , Novartis Us External Communications ,

40 personalidades de la sanidad reclaman un esfuerzo para frenar la tercera ola

40 personalidades de la sanidad reclaman un esfuerzo para frenar la tercera ola
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