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发布日期:2021年12月06日
 
Iron deficiency and Iron deficiency anaemia

Iron deficiency and iron deficiency anaemia are highly common conditions present in up to one third of people worldwide1. Iron is a fundamental mineral needed to produce haemoglobin, a protein in red blood cells that carries oxygen around the body. Iron deficiency indicates a condition in which iron levels are below the minimal

threshold. If iron levels fall too low and are not treated, the body is unable to produce an adequate amount of haemoglobin and healthy red blood cells. This condition is called iron deficiency anaemia which results in symptoms affecting quality of life.

FERINJECT®

Ferinject® (ferric carboxymaltose) is an intravenous (i.v.) iron indicated for the treatment of iron deficiency and iron deficiency anaemia, where oral iron is ineffective or cannot be used or when there is a clinical need to deliver iron rapidly.

Among others, iron deficiency and iron deficiency anaemia are especially common in patients who suffer from chronic kidney disease (CKD), heart failure and inflammatory bowel disease. It is also a condition affecting patients in preoperative and perioperative situations, as well as premenopausal women, including women affected by heavy menstrual bleeding and in peri-partum.

In the US, Ferinject® is commercialised under the brand name Injectafer®. Ferinject® has received market approval in 82 countries.

How does Ferinject® work?

The active ingredient of Ferinject®, ferric carboxymaltose, is composed of a poly-nuclear iron core stabilised by a carboxymaltose shell that ensures an effective iron utilisation. When injected, this complex releases the iron, which will be either stored or exported in the blood plasma for transportation and utilisation where it is needed.

VENOFER®

Venofer® (iron sucrose (iron (III)-hydroxide sucrose complex) is a low-dose intravenous (i.v.) iron sucrose product, used for i.v. treatment of iron deficiency when oral iron preparations are ineffective or cannot be used e.g .in anaemic dialysis patients

Venofer® is a nanomedicine, recognised by the US Food and drug administration.2 Scientific evidence demonstrates that nanomedicine similars have a different efficacy and safety profile compared with Venofer®.3,4

How does Venofer® work?

For patients suffering from kidney disease, kidney dysfunction can lead to a deficit in the production of erythropoietin (EPO), a natural hormone produced by the kidneys, which regulates the production of red blood cells. Therefore, a deficit in EPO leads to a deficit in red blood cells, a condition known as anaemia. Venofer®, taken with medications that stimulate the production of EPO, increases iron levels, allowing the body to effectively produce more red blood cells and control anaemia.

MIRCERA® & RETACRIT®

ERYTHROPOIESIS-STIMULATING AGENT (ESA) PORTFOLIO

MIRCERA®

Mircera®(methoxy polyethylene glycol-epoetin beta) is a long-acting erythropoiesis-stimulating agent (ESA) licensed from F. Hoffmann-La Roche AG in 2015 to treat symptomatic anaemia associated with chronic kidney disease. Mircera® is a core part of Vifor Pharma’s renal anaemia strategy and is supplied to over 3,000 dialysis clinics in the US and its territories.

Mircera.com (US Healthcare Professionals Only)

RETACRIT®

Retacrit®is a short-acting erythropoiesis-stimulating agent (ESA) approved by the US Food and Drug Administration (FDA) in May 2018. It is the first biosimilar ESA approved in the US. Vifor Pharma licensed rights from Pfizer Inc., in 2015 to commercialise Retacrit® in the US dialysis and non-hospital market, enabling Vifor Pharma to offer customers a full range of ESA treatment options to support patient needs.

How do Mircera® and Retacrit® work?

Erythropoietin (EPO) is a natural hormone produced by the kidneys, which regulates the production of red blood cells. For patients with kidney disease, kidney dysfunction can lead to a deficit in the production of EPO, resulting in a significant decrease in the production of red blood cells, a condition known as anaemia. In dialysis patients, advanced kidney impairments lead to a lack of natural EPO, which results in severe anaemia. In these cases, treatment with ESA’s is recommended because they act in place of natural EPO to stimulate red blood cell production. Short-acting ESAs are typically administered two to three times a week. Long-acting ESAs have been designed to have a much longer lasting effect, allowing for dosing once or twice a month.

Hyperkalaemia

Hyperkalaemia is a serious problem for cardio-renal patients, which can lead to cardiac arrhythmias, cardiac arrest and death. It is often triggered by treatment with RAASi (renin-angiotensin-aldosterone system inhibitors),

which are a cornerstone of treatment for conditions including hypertension and heart failure. As a consequence, RAASi therapy is often reduced or discontinued, compromising cardio-renal protection.4

VELTASSA®

Veltassa® (patiromer) is an oral calcium-based potassium binder indicated for the treatment of hyperkalaemia, a condition characterised by elevated levels of potassium in the blood. This can lead to potentially life-threatening cardiac arrhythmia and particularly affects patients with kidney disease, hypertension, diabetes and/or heart failure.5

Veltassa® is able to offer an effective and well tolerated innovation for the long-term management of hyperkalaemia in chronic heart failure and chronic kidney disease patients. It is commercialised in the U.S. and in 12 European countries.

How does Veltassa® work?

Taken as a powder in suspension, Veltassa® acts within the gastrointestinal tract, binding to potassium in exchange for calcium. The potassium is then removed from the body through the normal excretion process. This way, Veltassa® enables patients to remain on RAASi therapy while managing their chronic hyperkalaemia.6

Hyperphosphatemia

Patients with severe renal failure are unable to eliminate phosphorus from the body. The consequence is hyperphosphatemia, a condition characterised by

high levels of phosphate in the blood, which in the long term can cause complications such as heart disease and bone disease.

VELPHORO®

Velphoro® (Polynuclear Iron (III)-Oxyhydroxide, Sucroferric Oxyhydroxide) is a non-calcium, iron-based chewable phosphate binder developed for the treatment of hyperphosphatemia, in adults with chronic kidney disease undergoing dialysis. At the end of 2019, Velphoro® was registered in 42 countries.

How does Velphoro® work?

The active ingredient of Velphoro® is a phosphate binder. When taken with meals, the iron contained in Velphoro® binds to the phosphate in food that passes through the intestine, preventing its absorption into the body, therefore helping to keep phosphate levels in the blood low.

The strong binding capacity of Velphoro® allows patients to maintain target serum phosphate levels with half the pill burden.8 A lower pill burden can increase adherence, leading to an effective control of phosphate levels.

Diabetic Kidney Disease

Nearly half of all patients with type 2 diabetes can expect to develop diabetic kidney disease which causes a high risk of kidney failure and cardiovascular disease.

INVOKANA®

In November 2019, Vifor Pharma announced a new commercial partnership with Janssen Pharmaceuticals Inc., part of Johnson & Johnson, to jointly commercialise Invokana® (canagliflozin) in the US to treat diabetic kidney disease (DKD). It is already available in the US to reduce the risk of major cardiovascular events and improve glycemic control in patients with type 2 diabetes.

Invokana® is the only product in the class of sodium-glucose co-transporter-2 inhibitors (SGLT2s), indicated to slow the progression of DKD, and reduce the risk of hospitalisation for heart failure in patients with type 2 diabetes and DKD. In addition to the current standard of care, Invokana® represents an important advancement in treatment options for this large and underserved patient population.

How does INVOKANA® work?

INVOKANA®, used in combination with a healthy diet and exercise, helps to lower blood sugar (glucose) levels in adults with type 2 diabetes, and reduces the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes who have known cardiovascular disease.

Nephrology
Pipeline

Vifor Pharma has established a clear leadership position in nephrology with a broadening pipeline of innovative products and services. By investing in our pipeline and

ensuring we have the right people and organisation for success, Vifor Pharma Group continues to make excellent progress.

ANAEMIA IN CHRONIC KIDNEY DISEASE

Vadadustat

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor under investigation for the treatment of anaemia due to chronic kidney disease in non-dialysis and dialysis-dependent patients. It is currently in global phase-III development by Akebia Therapeutics, Inc., with and Vifor Pharma has been granted an exclusive license to sell vadadustat to Fresenius Kidney Care dialysis centres. Identified as a key regulator of the body’s natural reaction to low oxygen conditions (hypoxia), the HIF pathway increases erythropoietin (EPO) production when there is lower oxygen availability. In return, erythropoietin triggers the production of red blood cells.

How does vadadustat work?

Vadadustat activates the HIF pathway, resulting in a temporary hypoxic-like state that stimulates the production of erythropoietin, which leads to the production of red blood cells. Higher erythropoietin levels, achieved through the activation of HIF, may improve the management of anaemia in patients resistant to treatment with erythropoiesis-stimulating agents (ESA).

ANCA-ASSOCIATED VASCULITIS

avacopan

Avacopan is an orally-administered drug that inhibits the complement C5a receptor (C5aR) and it is being developed for patients with ANCA-associated vasculitis (AAV). The complement system is a group of proteins that work together to destroy foreign invaders (such as bacteria and viruses) and triggers the first inflammatory response to infection. The complement system must be carefully regulated so it is activated only when needed and does not attack the body’s healthy cells.

ANCA vasculitis is a systemic disease characterised by the over-activation of the complement system, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target. It is now a relapsing remitting long term condition with a high risk of acute mortality and cumulative organ damage from both the disease and the current therapy which includes high dose glucocorticoids.

How does avacopan work?

Avacopan specifically binds to the C5aR and so blocks the activity of C5a – this is the key end product of the complement system which attracts and activates more neutrophils (blood white cells) which are responsible for the acute damage to small blood vessels in AAV. Avacopan is a targeted therapy for AAV and stops the vicious inflammatory cycle causing organ damage

The positive pivotal phase-III ADVOCATE trial, demonstrated avacopan results in significantly more sustained remission compared to glucocorticoid based therapy. In addition benefits in terms of improved quality of life and renal function were observed with avacopan.8

CHRONIC KIDNEY DISEASE - ASSOCIATED PRURITUS

Difelikefalin

Difelikefalin is a peripherally restricted kappa opioid agonist, developed by Cara Therapeutics Inc. that targets the body’s peripheral nervous system. It is being developed as a treatment for chronic kidney disease-associated pruritus (CKD-aP), which is a systemic itch condition that affects patients undergoing haemodialysis and peritoneal dialysis. Vifor Fresenius Medical Care Renal Pharma entered into a development and licensing agreement with Cara Therapeutics to commercialise Difelikefalin injection worldwide (excluding the US, Japan and South Korea).

Moderate-to-severe chronic kidney disease-associated pruritus is associated with poor quality of life, depression, and is an independent predictor of mortality among haemodialysis patients.10

There are currently no approved therapies in Europe or the US for treatment of CKD-aP

Due to the high unmet patient need, the US Food and Drug Administration has granted breakthrough therapy designation to Difelikefalin for the treatment of CKD-aP in haemodialysis patients.

How does Difelikefalin work?

Difelikefalin acts as an analgesic, by activating the K-opioid-receptors in the peripheral nervous system and in the immune system. Therefore, it reduces the transmission of pain signals and reduces the release of prostaglandins, which cause the itching.

Kappa-opioid agonists have been specifically designed to mitigate the drawbacks or side effects typically observed with opiates, such as hallucination or opioid addiction.11

Results from the KALM-2 pivotal phase III trial demonstrated that that Difelikefalin significantly reduce itch intensity, it was generally well-tolerated with a safety profile consistent with that seen in previous trials.

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SECONDARY HYPERPARATHIROIDISM

Rayaldee®

Rayaldee® is an orally administered, extended-release formulation of calcifediol for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) with vitamin D insufficiency. Vifor Fresenius Medical Care Renal Pharma obtained the rights from OPKO Health Inc., for this indication in Europe, and selected markets outside Europe and the United States.

Secondary Hyperparathyroidism is a chronic progressive disease which increases in severity as CKD worsens. It is estimated to affect between 40% and 82% of patients with stage three or four CKD.12 There is currently no established standard of care for the treatment of SHPT in non-dialysis (ND-CKD) patients across Europe.

The disease occurs as a consequence of the declining kidney function and is related to disturbances in the levels of the parathyroid hormone and in the inter-correlated mineral and bone parameters calcium and phosphate. These imbalances are frequently accompanied by low levels of vitamin D.

How does Rayaldee® work?

Rayaldee® is the first and only oral extended-release formulation of calcifediol (25-hydroxyvitamin D), a pro-hormone of the active form of vitamin D. With its unique formulation, the active ingredient in Rayaldee® gradually increases vitamin D levels and decreases the levels of parathyroid hormone in a person’s blood, allowing the control of SHPT.

Administrated as a once-daily oral evening dose, it avoids monitoring beyond the frequency of routine laboratory assessments. It is well tolerated, with low rates of discontinuation.13,14

PATIENT STORIES

IRON PRODUCTS

CARDIO-RENAL PRODUCTS

REFERENCES