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Investegate |NOVARTIS AG CHF0.50(REGD) Announcements | NOVARTIS AG CHF0.50(REGD): Novartis Phase III Beovu® data show potential for fluid resolution in more diabetic macular edema patients with fewer injections versus aflibercept


NOVARTIS AG CHF0.50(REGD)
Novartis Phase III Beovu® data show potential for fluid resolution in more diabetic macular edema patients with fewer injections versus aflibercept
Novartis Phase III Beovu® data show potential for fluid resolution in more diabetic macular edema patients with fewer injections versus aflibercept
In KESTREL and KITE, Beovu (brolucizumab) 6 mg met the primary endpoints of non-inferiority in change in best corrected visual acuity from baseline versus aflibercept 2 mg at year one in diabetic macular edema (DME) patients
1
More patients treated with Beovu 6 mg experienced fluid (IRF/SRF) resolution at week 32 and week 52 versus aflibercept; fluid is a key marker of disease activity in DME ....

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Novartis International AG: Novartis reports positive topline results from second Phase III trial of Beovu in patients with diabetic macular edema


Novartis International AG: Novartis reports positive topline results from second Phase III trial of Beovu in patients with diabetic macular edema
,
Beovu (brolucizumab 6 mg) achieved its primary endpoint of non-inferiority to aflibercept 2 mg in change in best-corrected visual acuity (BCVA) at year one (week 52)
1
In a secondary endpoint, more than half of Beovu patients in the 6 mg arm were maintained on a three-month dosing interval through year one, following the loading phase
1
Significant improvement with Beovu 6 mg in change of central subfield thickness (CST) from baseline over the period of week 40 through week 52 was observed
1
1
Novartis intends to submit the data from KESTREL, together with the data from the pivotal Phase III KITE ....

United States , Eric Althoff , Isabella Zinck , Dirk Sauer , Thomas Hungerbuehler , Amy Wolf , Indianj Ophthalmol , Samir Shah , Beovu Basel , Sloan Simpson , Kite Pharma Inc , Novartis Division Communications , Novartis Us External Communications , Novartis External Communications , Exchange Commission , Canadian Drug Expert Committee Recommendation , Global Head Development , National Eye Institute , National Health Insurance Pricing , Canadian Agency For Drugs , Technologies In Health , Association For Research , Novartis Pharma , Kite Pharma , Patients With Visual Impairment Due , Diabetic Macular Edema ,

Novartis reports positive topline results from second Phase III trial of Beovu in patients with diabetic macular edema


Posted December 15th, 2020 for Novartis
In Phase III KESTREL study
,
Beovu (brolucizumab 6 mg) achieved its primary endpoint of non-inferiority to aflibercept 2 mg in change in best-corrected visual acuity (BCVA) at year one (week 52)
1
In a secondary endpoint, more than half of Beovu patients in the 6 mg arm were maintained on a three-month dosing interval through year one, following the loading phase
1
Significant improvement with Beovu 6 mg in change of central subfield thickness (CST) from baseline over the period of week 40 through week 52 was observed
1
1
Novartis intends to submit the data from KESTREL, together with the data from the pivotal Phase III KITE ....

United Kingdom , United States , Eric Althoff , Isabella Zinck , Dirk Sauer , Thomas Hungerbuehler , Amy Wolf , Indianj Ophthalmol , Samir Shah , Beovu Basel , Sloan Simpson , Kite Pharma Inc , Novartis Division Communications , Novartis Us External Communications , Novartis External Communications , Exchange Commission , Canadian Drug Expert Committee Recommendation , Global Head Development , National Eye Institute , National Health Insurance Pricing , Canadian Agency For Drugs , Technologies In Health , Association For Research , Novartis Pharma , Kite Pharma , Patients With Visual Impairment Due ,

Novartis reports positive topline results from second Phase III trial of Beovu® in patients with diabetic macular edema – IT Business Net


In Phase III KESTREL study
,
Beovu (brolucizumab 6 mg) achieved its primary endpoint of non-inferiority to aflibercept 2 mg in change in best-corrected visual acuity (BCVA) at year one (week 52)
1
In a secondary endpoint, more than half of Beovu patients in the 6 mg arm were maintained on a three-month dosing interval through year one, following the loading phase
1
Significant improvement with Beovu 6 mg in change of central subfield thickness (CST) from baseline over the period of week 40 through week 52 was observed
1
1
Novartis intends to submit the data from KESTREL, together with the data from the pivotal Phase III KITE
2
study in DME, to health authorities in H1 2021 ....

United States , Eric Althoff , Isabella Zinck , Dirk Sauer , Thomas Hungerbuehler , Amy Wolf , Indianj Ophthalmol , Samir Shah , Beovu Basel , Sloan Simpson , Kite Pharma Inc , Novartis Division Communications , Novartis Us External Communications , Novartis External Communications , Exchange Commission , Canadian Drug Expert Committee Recommendation , Global Head Development , National Eye Institute , National Health Insurance Pricing , Canadian Agency For Drugs , Technologies In Health , Association For Research , Novartis Pharma , Kite Pharma , Patients With Visual Impairment Due , Diabetic Macular Edema ,