Chronic immune diseases

Bowel diseases

• Budesonide

  • Jorveza 0.2 mg/mL oral suspension is indicated for the treatment of eosinophilic esophagitis (EoE) in paediatric patients 2 to 17 years of age.

• Etrasimod

  • For the treatment of patients aged 16 years and older with moderately to severely active ulcerative colitis (UC) who have an inadequate response, no longer respond to, or are intolerant of conventional treatment or a biological agent.
• Glepaglutide

• Golimumab

  • Simponi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients 2 years of age and older with a body weight of at least 15 kg, who have had an inadequate response to conventional therapy, including corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

• Guselkumab

  • Tremfya is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment.

• Mirikizumab

  • Omvoh is indicated for the treatment of adult patients with moderately to severely active Crohnʼs disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
• Obefazimod

• Teduglutide

  • Treatment of Short Bowel Syndrome.
• Tegoprazan

• Ustekinumab

  • Stelara is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.
  • Extension of indication to include treatment of ulcerative colitis in paediatric patients from the age of 2 years and older.

• Vedolizumab

  • Ulcerative colitis (UC) and of Crohn’s disease (CD) in the paediatric population from 2 to less than 18 years for Entyvio 300 mg powder for concentrate for solution for infusion.

Eye disorders

• Veligrotug

Other chronic immune diseases

• 13-grass pollen extract
• Allergeenextract huisstofmijt ^IND
• Atacicept
• Atrasentan

• Berotralstat

  • Berotralstat monotherapy for prophylactic treatment of hereditary angioedema in children aged 2 to 12.

• Bezuclastinib

  • Bezuclastinib monotherapy for treatment of advanced systemic mastocytosis in adults and elderly.
  • Bezuclastinib in combination with best supportive care for treatment of moderate to severe nonadvanced systemic mastocytosis in adults and elderly whose symptoms are not adequately controlled.

• Budesonide

  • Kinpeygo is indicated for the treatment of adults with a urine protein excretion-to-creatinine ratio (UPCR) ≥1,0g/dayg (or urine protein-to-creatinine ratio ≥0,8g/g).

• Crovalimab

  • Crovalimab is Indicated for Adult and Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS).
• Deucrictibant
• Donidalorsen

• Dupilumab

  • Dupixent is geïndiceerd voor de behandeling van eosinofiele oesofagitis in volwassenen, adolescenten en kinderen van een jaar en ouder. Die ongecontroleerd zijn op, intolerant zijn voor, of die geen kandidaat zijn voor conventionele therapie.

• Emapalumab

  • Treatment of acute or recurrent secondary haemophagocytic lymphohistiocytosis (sHLH) in adult and paediatric patients (6 months and older).
• Epinefrine ^IND
• Ianalumab

• Imlifidase

  • Imlifidase in combination with standard of care for treatment of severe anti-glomerular basement membrane disease in adults and elderly.

• Iptacopan

  • Fabhalta is indicated for the treatment of adult patients with complement 3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, or in patients who are RAS-inhibitor intolerant, or for whom a RAS inhibitor is contraindicated.

• Leniolisib

  • Leniolisib monotherapy for treatment of Activated PI3 kinase delta syndrome in infants, toddlers and children between 1 to 12 years of age.
  • Joenja is indicated for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more.
• Lonvoguran ziclumeran
• Marnetegragene autotemcel
• Mavorixafor

• Obinutuzumab

  • Childhood onset Idiopathic Nephrotic Syndrome (INS).
  • Gazyvaro in combinatie met mycofenolaatmofetil (MMF) is geïndiceerd voor de behandeling van volwassen patiënten met actieve lupus nefritis (LN) van klasse 3 of 4, met of zonder gelijktijdige klasse 5.

• Pegcetacoplan

  • Aspaveli is indicated for the treatment of adult and adolescent patients aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.

• Sarilumab

  • Kevzara is indicated for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper.
• Sebetralstat

• Secukinumab

  • Extension of indication to include treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adolescents 12 years and older with an inadequate response to conventional systemic HS therapy for COSENTYX
• Sibeprenlimab
• Tadekinig alfa

• Tezepelumab

  • Tezepelumab monotherapy for treatment of Eosinophilic oesophagitis in adolescents, adults and elderly with previously documented standard of care treatment.

• Upadacitinib

  • Moderate to severe Hidradenitis suppurativa in adolescents, adults and elderly who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy.
  • Treatment of severe alopecia areata (AA) in adult and adolescents 12 years and older.

Rheumatism

• Anifrolumab

  • Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus (SubQ Tulip).
  • Active Proliferative Lupus Nephritis (IRIS)
• Brepocitinib
• Dapansutrile

• Deucravacitinib

  • Extension of indication to include treatment of adult patients with moderate-to-severe SLE (exact indication text to be confirmed).
  • Sotyktu, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy (see section 5.1).

• Filgotinib

  • Treatment of axial spondyloarthritis in adult patients with active radiographic axial spondyloarthritis (r-axSpA) and with active non-radiographic axial spondyloarthritis (nr-axSpA).

• Golimumab

  • Golimumab-lvtc in combination with methotrexate for treatment of moderate to severe active rheumatoid arthritis in adults and elderly.

• Inebilizumab

  • Uplizna is indicated for the treatment of adult patients with active IgG4-RD (see section 5.1).
• Litifilimab
• Obexelimab

• Obinutuzumab

  • Treatment of adult patients with active systemic lupus erythematosus (SLE) who are receiving standard therapy.

• Secukinumab

  • Extension of indication to include polymyalgia rheumatica in adults whose disease has responded inadequately to, or cannot tolerate conventional therapy.

• Tofacitinib

  • Tofacitinib monotherapy for treatment of Ankylosing spondylitis, Psoriatic arthritis, Rheumatoid arthritis, Ulcerative colitis, Juvenile idiopathic arthritis in children from 2 years of age and adults.

• Upadacitinib

  • Rinvoq is indicated for the treatment of giant cell arteritis in adult patients.
  • Upadacitinib monotherapy for treatment of moderately to severely active Systemic lupus erythematosus in adults.
  • Extension of indication to include the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.

Skin diseases

• Afamelanotide

  • Afamelanotide in combination with Narrow-Band Ultraviolet B (NB-UVB) light for treatment of stable or active generalized Vitiligo in adolescents, adults and elderly.
• Amlitelimab

• Baricitinib

  • Baricitinib is indicated for the treatment of severe alopecia areata in adult and adolescent patients 12 years of age and older (see section 5.1).
• Beremagene geperpavec
• Clascoterone

• Delgocitinib

  • Extension of indication to include treatment of adolescents 12 years and older with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.
• Deuruxolitinib

• Dupilumab

  • Treatment of adults with bullous pemphigoid (BP).
  • Extension of indication to include treatment of moderate to severe chronic spontaneous urticaria in adults and adolescents 12 years and older, whose disease is inadequately controlled by H1 antihistamines and who are naive to anti-IgE therapy for CSU.
  • Dupixent is indicated for the treatment of moderate to severe chronic spontaneous urticaria in adults, adolescents, and children (2 years and above) with inadequate response to H1 antihistamines and who are naive to anti-IgE therapy for CSU.

• Guselkumab

  • Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy
• Humane allogene, uit de huid afkomstige ABCB5+ mesenchymale stromale cellen
• Icotrokinra
• Imsidolimab

• Lebrikizumab

  • Lebrikizumab in combination with topical corticosteroid for treatment of moderate to severe atopic dermatitis in infants, toddlers over 6 months, children and adolescents.
• Nemolizumab

• Povorcitinib

  • Vitiligo
  • Voor de behandeling van actieve matige tot ernstige hidradenitis suppurativa (HS) bij volwassenen met een ontoereikende respons op conventionele systemische hidradenitis suppurativa therapie.
  • Prurigo nodularis (PN)
• Prademagene zamikeracel
• Remibrutinib

• Risankizumab

  • Extension application to include treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.

• Ritlecitinib

  • Treatment of patients with non-segmental vitiligo.

• Ruxolitinib (als fosfaat)

  • Extension of indication to include treatment of moderate atopic dermatitis in adult patients who are inadequately controlled with, have a contraindication to, or are intolerant to topical corticosteroids and topical calcineurin inhibitors.
  • Prurigo nodularis (PN).
• Ruxolitinib als fosfaat ^IND
• Tirbanibuline ^IND

• Upadacitinib

  • Non-segmental Vitiligo in adolescents, adults and elderly who are eligible for systemic therapy.
• Zasocitinib