Sparsentan, sold under the brand name Filspari, is a
medication
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field an ...
used for the treatment of
primary immunoglobulin A nephropathy.
Sparsentan is an endothelin and angiotensin II receptor antagonist.
It is taken
by mouth
Oral administration is a route of administration where a substance is taken through the mouth. Per os abbreviated to P.O. is sometimes used as a direction for medication to be taken orally. Many medications are taken orally because they are i ...
.
The most common side effects include swelling of the extremities, low blood pressure, dizziness, high blood potassium, anemia, injury to the kidney, and increased liver enzymes in the blood.
It was approved for medical use in the United States in February 2023.
[ ] The US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) considers it to be a
first-in-class medication A first-in-class medication is a pharmaceutical that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medica ...
.
Medical uses
Sparsentan is
indicated
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...
to reduce
proteinuria
Proteinuria is the presence of excess proteins in the urine. In healthy persons, urine contains very little protein; an excess is suggestive of illness. Excess protein in the urine often causes the urine to become foamy (although this symptom ma ...
in people with primary immunoglobulin A nephropathy.
Adverse effects
The most common side effects include swelling of the extremities, low blood pressure, dizziness, high blood potassium, anemia, injury to the kidney, and increased liver enzymes in the blood.
Other potential risks of sparsentan include low blood pressure, injury to the kidney, high potassium in the blood, and fluid retention.
Sparsentan can cause changes in liver tests.
Some medicines that are like sparsentan can cause liver failure.
Sparsentan can cause serious birth defects if taken during pregnancy and should not be started in someone who is pregnant.
History
Sparsentan was discovered by
Pharmacopeia, Inc.
Pharmacopeia was a public biotechnology company that pioneered the field of small molecule combinatorial chemistry.
Pharmacopeia was founded by Larry Bock and Drs. Michael Wigler, Clark Still and Jack Chabala.
Pharmacopeia went public in 1 ...
and developed as PS433540 as their lead compound in a new class of agents called dual acting receptor antagonists (DARA). PS433540 was originally developed as a treatment for hypertension and diabetic nephropathy. After Pharmacopeia was acquired by
Ligand Pharmaceuticals
Ligand Pharmaceuticals is a biopharmaceutical company located in San Diego, California. Founded in 1987 as Progenix Inc., the company went public in 1992. Initially focused on developing its own drugs, a period of turbulence in the early 2000s cul ...
, the DARA programs was licensed to Retrophin and developed as RES-021 in 2012. Retrophin would then be rebranded as Travere Therapeutics.
Sparsentan was evaluated in a randomized, double-blind, active-controlled, clinical trial (PROTECT) in participants with IgA nephropathy.
Participants with IgA nephropathy and protein in the urine were randomly assigned to receive either sparsentan or irbesartan once daily.
The primary endpoint for accelerated approval was the mean change in urine protein at week 36 compared to baseline.
The US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) granted accelerated approved to sparsentan based on evidence from a clinical trial (PROTECT) of participants with IgA nephropathy.
The trial was conducted at 156 sites in 18 countries in North America, Europe, and Asia-Pacific.
The same trial was used to assess both efficacy and safety.
The efficacy analyses were based on an interim analysis of 281 participants (141 on sparsentan, 140 on irbesartan) who reached week 36 in the trial.
The safety analyses were based on 404 participants (202 each on sparsentan and irbesartan) who received at least one dose of either drug.
Society and culture
Legal status
Sparsentan was approved in the US under
accelerated approval The United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need. The faster approval relies on use of surrogate en ...
based on reduction of proteinuria.
In September 2024, the US FDA converted the conditional approval in the kidney disease IgA nephropathy (IgAN) into a full approval based on positive long-term confirmatory results from the PROTECT Study demonstrating that sparsentan significantly slowed kidney function decline over two years compared to irbesartan.
In February 2024, the
Committee for Medicinal Products for Human Use
The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee
A committee or commission is a body of one or more persons subordin ...
of the
European Medicines Agency adopted a positive opinion recommending the granting of a conditional marketing authorization for the medicinal product Filspari, intended for the treatment of adults with primary immunoglobulin A nephropathy (IgAN).
The applicant for this medicinal product is Vifor France.
[ Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.] Sparsentan was approved for medical use in the European Union in April 2024.
References
External links
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{{Authority control
Orphan drugs