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Disease

familial Mediterranean fever

Late-stage therapeutic development
Also known as FMF, Fiebre mediterránea familiar, benign paroxysmal peritonitis, benign recurrent polyserositis+2 more

FMF, Fiebre mediterránea familiar, benign paroxysmal peritonitis, benign recurrent polyserositis, familial paroxysmal polyserositis, periodic disease.

9
Clinical trials
2
Associated genes
1
Related proteins
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

Approval: Ilaris (EMA)

Regulatory2009-10-23EMA

Approval: Kineret (EMA)

Regulatory2002-03-08EMA

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Low
Key developments
  • 1 clinical trial with recent milestones.
Clinical Milestones1View
Other updates 1
Activity timeline1

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Canakinumabapproved

Approval — Periodic fever syndromes Ilaris is indicated for the treatment of the following autoinfla… (2009)

Anakinraapproved

Approval — Rheumatoid Arthritis (RA) Kineret is indicated in adults for the treatment of the signs a… (2002)

Clinical trials

8 sponsors · 1 new · 0 completed in the last 12 months (net +1)

The current development programme across all trial phases.

Clinical programme
9
All trials
1
Active
3
Late-stage
6
Completed
Recently completed

Tocilizumab for the Treatment of Familial Mediterranean Fever - A Randomized, Doubleblind, Phase II Proof of Concept Study

Phase 2 · Completed · University Hospital Tuebingen

A Randomized Placebo-Controlled Study of the Efficacy and Safety of Kineret (Anakinra), in Adult Patients With Colchicine-Resistant Familial Mediterranean Fever

Phase 3 · Completed · Sheba Medical Center

The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With Familial Mediterranean Fever: A Randomized Trial

Phase 4 · Completed · Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

A 6 Month Phase 2, Multi-Center, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Treatment With Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever

Phase 2 · Completed · Novartis Pharmaceuticals

Phase 2 Study of IL-1 Trap (Rilonacept) for Treatment of Familial Mediterranean Fever (FMF)

Phase 2 · Completed · The Cleveland Clinic

An Open-label, Exploratory Study to Establish the Safety and Efficacy of 3 Months Treatment With Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever

Phase 2 · Completed · Novartis Pharmaceuticals

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2009emaApproval — Canakinumab· Periodic fever syndromes Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older: Cryopyrin-associated periodic syndromes Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including: Muckle-Wells syndrome (MWS), Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA), Severe forms of familial cold autoinflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash. Tumour necrosis factor receptor associated periodic syndrome (TRAPS) Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS). Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD). Familial Mediterranean fever (FMF) Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF). Ilaris should be given in combination with colchicine, if appropriate. Ilaris is also indicated for the treatment of: Still’s disease Ilaris is indicated for the treatment of active Still’s disease including adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate. Gouty arthritis Ilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate. source ↗
2002emaApproval — Anakinra· Rheumatoid Arthritis (RA) Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response to methotrexate alone. COVID-19 Kineret is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (suPAR) ? 6 ng/ml. Periodic fever syndromes Kineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above: Cryopyrin-Associated Periodic Syndromes (CAPS) Kineret is indicated for the treatment of CAPS, including: Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA) Muckle-Wells Syndrome (MWS) Familial Cold Autoinflammatory Syndrome (FCAS) Familial Mediterranean Fever (FMF) Kineret is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret should be given in combination with colchicine, if appropriate. Still’s Disease Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs). source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Associated genes

2 matches

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

MEFV0.81IL1B0.51

Disease biology

1 match

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

Interleukin-1 betavia IL1B0.51

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

A group of HEREDITARY AUTOINFLAMMATION DISEASES, characterized by recurrent fever, abdominal pain, headache, rash, PLEURISY; and ARTHRITIS. ORCHITIS; benign MENINGITIS; and AMYLOIDOSIS may also occur. Homozygous or compound heterozygous mutations in marenostrin gene encoding PYRIN result in autosomal recessive transmission; simple heterozygous, autosomal dominant form of the disease also exists with mutations in the same gene.

Synonyms

FMF, Fiebre mediterránea familiar, benign paroxysmal peritonitis, benign recurrent polyserositis, familial paroxysmal polyserositis, periodic disease

References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.