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Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 18, 2020
Details:
The U.S. Food and Drug Administration (FDA) has not raised any concerns related to the efficacy or safety of inclisiran. The complete response letter is due to unresolved facility inspection-related conditions.
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Lead Product(s): Sacubitril Sodium,Valsartan
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Entresto
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2020
Details:
The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF).
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Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2020
Details:
Pooled data analyses from Phase III ORION-9, -10 and -11 showed that inclisiran consistently reduced low-density lipoprotein cholesterol (LDL-C) by approximately 51% in both male and female adult patients and in three age categories.
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Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2020
Details:
Inclisiran provides effective and sustained reduction of LDL-C of up to 52%, with a safety profile similar to placebo, in patients with elevated LDL-C despite maximally tolerated lipid-lowering therapy.
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Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: KJX839
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2020
Details:
Pooled data from Phase III ORION-10 and -11 showed highly consistent efficacy, tolerability and safety profile over 17 months on twice-yearly subcutaneous dosing in 2,300 patients (of which 1,164 were on inclisiran).
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Lead Product(s): Selexipag,Macitentan,Tadalafil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Uptravi
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 29, 2020
Details:
While the primary endpoint was not met, exploratory analysis suggests a signal of reduced risk of disease progression of initial triple oral combination therapy vs initial double oral therapy for Pulmonary Arterial Hypertension (PAH) patients .
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Lead Product(s): Canakinumab
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Ilaris
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2020
Details:
In a study of Ilaris in 10,000 patients with a history of heart attack it is found that people taking the drug had 40% to 47% lower rates of total knee or hip replacements than did those taking a placebo.
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Lead Product(s): Aprocitentan
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $341.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering May 20, 2020
Details:
The net proceeds from this offering will help Idorsia to prepare to launch its first commercial product and continue to fund the development of its pipeline candidates including aprocitentan, clazosentan and lucerastat, as well as its early-stage and preclinical pipeline.
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Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2020
Details:
Prespecified analysis of pooled data from ORION-9, -10 and -11 Phase III clinical trials shows inclisiran reduced low-density lipoprotein-cholesterol (LDL-C) by 51% at 17 months.
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Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status:
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