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Details:
Leqvio (inclisiran), the first and only approved small interfering RNA (siRNA) therapy to lower LDL-C, gains expanded approval for the treatment of adults with high LDL-C and who are at increased risk of heart disease.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2024
Details:
Leqvio (Inclisiran) is the first and only small interfering RNA (siRNA) therapy to lower LDL-C. It is approved in over 80 countries, including the US, EU and China.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 28, 2023
Details:
Leqvio (inclisiran), the first and only approved small interfering RNA (siRNA) therapy to lower LDL-C, gains expanded approval for the treatment of adults with high LDL-C and who are at increased risk of heart disease.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 10, 2023
Details:
Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C and is administered with 2 doses a year. Leqvio is important for ASCVD patients who are not reaching recommended LDL-C target levels despite taking other cholesterol-lowering medications.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 07, 2022
Details:
LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 26, 2022
Details:
The approval of Leqvio (Inclisiran) First siRNA is based on the ability of Leqvio to lower LDL cholesterol up to 52% in patients with Atherosclerotic Cardiovascular Disease.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2021
Details:
Treatment emergent adverse events (TEAEs) at the injection site were more frequent with Leqvio, but all were mild or moderate. The effect of Leqvio on cardiovascular morbidity and mortality has not been determined.
Lead Product(s): Inclisiran,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alnylam Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2021
Details:
Agreement follows positive NICE recommendation and commits to deliver Leqvio® (inclisiran) access via a population health management approach identifying eligible patients across England.
Lead Product(s): Inclisiran,Ezetimibe
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 01, 2021
Details:
Separate post hoc analyses of pooled Phase III ORION-9, -10 and -11 data show twice-yearly Leqvio® (inclisiran) consistently reduced LDL-C in patients with atherosclerotic cardiovascular disease with established cerebrovascular disease and polyvascular disease.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alnylam Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2021
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.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alnylam Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 18, 2020
Details:
Approval is based on the results of the robust ORION clinical development program, where Leqvio provided an effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction of up to 52% in patients with elevated LDL-C, despite maximally tolerated statin therapy.
Lead Product(s): Inclisiran,Statin Therapy
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alnylam Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 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.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alnylam Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 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.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Leqvio
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alnylam Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 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).
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: KJX839
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alnylam Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2020
Details:
Blackstone will Provide up to $2 Billion to Support Alnylam’s Advancement of Innovative RNA Interference (RNAi) Medicines that Have the Potential to Transform the Lives of Patients Suffering from a Range of Debilitating Diseases.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Blackstone Life Sciences
Deal Size: $2,000.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration April 13, 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.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: KJX839
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Alnylam Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2020
Details:
Inclisiran, an investigational medicine, showed durable and potent reduction of low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD).
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: KJX839
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2020
Details:
With this collaboration, Novartis aims to bring first-in-class cholesterol lowering drug via a world-first, population health model to large at risk NHS patient population with ACD.
Lead Product(s): Inclisiran
Therapeutic Area: Cardiology/Vascular Diseases Product Name: KJX839
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration January 13, 2020
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