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The EC has approved Xoanacyl (ferric citrate complex) for chronic kidney disease; UK's MAA was filed via MHRA's IRP
Approval was supported by 3 pivotal trials conducted by Akebia Therapeutics, which showed increased iron levels along with reduction in serum phosphorus in CKD pts
Averoa licensed Xoanacyl from Akebia in Dec 2022, enhancing its…
Chronic kidney disease is, in our opinion, one of the most underestimated health issues of all. Mainstream media usually discuss cancer and cardiovascular issues. However, did you know that only in the USA, around 35 million people are dealing with different types of kidney health issues? In other words, 1 in 7 US residents has…
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The CHMP has recommended Xoanacyl (ferric citrate complex) for chronic kidney disease, with an EU decision expected by Jun 2025, while the UK's MAA will be filed via MHRA's IRP, with decision anticipated in the coming mos.
MAA was filed via centralized European procedure in Mar 2024 & was supported by 3 pivotal trials…
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China’s NMPA has approved NDA of tenapanor for hyperphosphatemia in CKD pts on dialysis who inadequately responded or are intolerant to phosphorus binders
Approval was based on data from 2 Fosun Pharma studies (PK study & pivotal trial in CKD pts on dialysis), plus clinical studies from Ardelyx
Approval triggered $5M milestone…
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BI has launched Semintra (4mg/mL) in the EU for the treatment of systemic hypertension in cats
Semintra has shown clinical efficacy in reducing proteinuria & blood pressure, which may help restore kidney balance while also promoting cat’s appetite, activity levels, & QoL
Semintra (QD) is a telmisartan solution administered orally or on top…
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The US FDA has approved Ozempic to reduce the risk of kidney disease worsening & CV death in adults with type 2 diabetes & CKD
Approval was based on P-IIIb (FLOW) trial assessing Ozempic (1mg, Q1W, n=1767) vs matching PBO (n=1766) in type 2 diabetes & CKD pts (N=3533)
Study met its 1EP of 24% relative…
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Associated with early onset and rapid progression of chronic kidney disease (CKD), APOL1 Mediated Kidney Disease dramatically affects people of African descent
AstraZeneca is developing AZD2373, the first potential precision treatment option for the treatment of AMKD with Ionis Pharmaceuticals. Recently, AZ shared promising data from the early P-I data from the MAD study …
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Exemplifying awareness campaign at its best with a hint of contemporary music, “It takes 2” by Boehringer Ingelheim and Eli Lilly is a noble initiative aimed at integrating UACR testing with eGFR for better screening of CKD
Noelle Bush, in an engaging conversation with PharmaShots, cites the growing incidences of CKD in the US.…
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Mohamed Eid, VP of Clinical Development & Medical Affairs, Cardio-Renal-Metabolism & Respiratory Medicine, at Boehringer Ingelheim, in a stimulating conversation with PharmaShots sheds light on the recent approval of Jardiance for the treatment of adults with chronic kidney disease
Jardiance’s EMPA Kidney P-III trial results demonstrated a 28% relative risk reduction vs placebo. Jardiance…
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Dr. Navdeep spoke about the data presented at the ASN Kidney Week 2022 emphasizing on the urgent need for early screening of chronic kidney disease
Helen Yeh talked about the treatment of CKD with Farxiga. She also focused on the patient support programs by AstraZeneca for the early diagnosis and screening of patients
The…

