Details:
Jesduvroq (daprodustat), a HIF-PHI, which inhibis of oxygen-sensing prolyl hydroxylase enzymes stabilises hypoxia-inducible factors, which can lead to transcription of erythropoietin and other genes involved in the correction of anaemia.
Lead Product(s): Daprodustat
Therapeutic Area: Nephrology Product Name: Jesduvroq
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2023
Details:
Forxiga (dapagliflozin) also significantly reduced the relative risk of death from any cause by 31% (ARR=2.1%, p=0.0035) compared to placebo6. The safety and tolerability of Forxiga were consistent with the well-established safety profile of the medicine.
Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Forxiga
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 05, 2022
Details:
BENLYSTA (belimumab), a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. BENLYSTA does not bind B cells directly. First approved in 2011, it is the first and only approved biologic for both SLE and LN in more than 50 years.
Lead Product(s): Belimumab
Therapeutic Area: Nephrology Product Name: Benlysta
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2022
Details:
The designation is based on the potential of LOKELMA to reduce serious adverse CV outcomes in this patient population, addressing a significant unmet medical need.
Lead Product(s): Sodium Zirconium Cyclosilicate
Therapeutic Area: Nephrology Product Name: Lokelma
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2021
Details:
Approval is based on DAPA-CKD Phase III trial in which FARXIGA demonstrated unprecedented reduction in the risk of the composite of worsening of renal function, end stage kidney disease and cardiovascular or renal death.
Lead Product(s): Dapagliflozin
Therapeutic Area: Nephrology Product Name: Farxiga
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Ono Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 30, 2021
Details:
The approval by the NMPA was based on data from the Phase IIIb DIALIZE trial. The trial showed sustained potassium control pre-dialysis for more patients receiving Lokelma, compared with placebo.
Lead Product(s): Sodium Zirconium Cyclosilicate
Therapeutic Area: Nephrology Product Name: Lokelma
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2020
Details:
The European Commission approval is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation Phase III renal outcomes trial, which was stopped early based on the achievement of a pre-specified efficacy criterion.
Lead Product(s): Canagliflozin
Therapeutic Area: Nephrology Product Name: Invokana
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 02, 2020
Details:
The 20 abstracts being presented, will include data on Lokelma (sodium zirconium cyclosilicate), roxadustat & Farxiga (dapagliflozin) across different stages of CKD and AstraZeneca’s ongoing commitment to exploring treatment options across the full continuum of renal care.
Lead Product(s): Sodium Zirconium Cyclosilicate
Therapeutic Area: Nephrology Product Name: Lokelma
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 05, 2020