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Regeneron’s Veopoz scores FDA approval for rare immune disease

2023-08-21

上市批准临床结果临床2期免疫疗法

Phalguni Deswal

@Phalguni_GD

Veopoz’s approval was based on the data from the open-label Phase II/III trial (NCT04209634) consisting of ten participants. Image Credit: lev radin / Shutterstock.

Regeneron Pharmaceuticals has received US Food and Drug Administration (FDA) approvals for two of its drugs, namely Veopoz (pozelimab-bbfg) and high-dose Eylea (aflibercept) in the last few days.

Veopoz is the first drug which has been approved by the FDA for CD55 deficiency with hyperactivation of complement, angiopathic thrombosis, and protein-losing enteropathy or CHAPLE disease in patients aged one year and older.

Regeneron Pharmaceuticals Food and Drug Administration (FDA)Veopoz pozelimab-bbfg Eylea aflibercept

VeopozsLOA and PTSR Model - Siremadlin Succinate in MyelFDAsplasCD55Syndrome GlobalDataprotein-losing enteropathy CHAPLE disease

ReportsLOA and PTSR Model - Docetaxel Albumin Bound in Fallopian Tube Cancer GlobalData

View allCompanies IntelligenceBayer AGRegeneron Pharmaceuticals IncAlnylam Pharmaceuticals IncRegeneron GmbHView all

CHAPLE is a genetic immune dSiremadlin SuccinateatioMyelodysplastic Syndromeing overactivation of the complement system. This results in impaired inflammatory response and causes symptoms such as abdominal pain, recurrent infections, oedema, and diarrhoea.

Veopoz, a monoclonal antibody, targets and inhibits the protein involved in the activation of the complement system, the C5 complement factor.

Additionally, Eylea HD, which is being codeveloped by RFallopian Tube Canceras granted approval to treat ophthalmologic disorders such as wet age-related macular degeneration (wAMD), diabetic retinopathy (DR) and diabetic macular oedema (DME).

Veopoz’s approval was based on the data from the open-label Phase II/III trial (NCT04209634) consisting of 10 participants, who all achieved the primary outcome of normalised serum albumin at 12 weeks, with the patients maintaining these levels over 72 weeks of treatment.

At 48 weeks,genetic immune diseaseired an albumin transfusion,CD55pared to the period of 48 weeks before starting treatment, when five patients required a total of 60 transfusions. Additionally, tabdominal painre hospitalised for seveoedema in 48diarrhoeater starting treatment, compared to nine patients requiring hospitalisation for a cumulative 268 days in the period before starting treatment. Veopoz is administered through a 30mg/kg intravenous loading dose, followed by weekly weight-based subcutaneous doses.

Veopozst commonly observed adverse events were upper respiratory tract infection, fracture, urticaria (itchy rash), and hC5 complement factor

Approved theraEylea HD rare diseases have increased inRegeneronin reBayeryears, with GlobalData forecastiophthalmologic disordersproval inwet age-related macular degeneration (wAMD)diabetic retinopathy (DR)diabetic macular oedema (DME)

VeopozData is the parent company of Pharmaceutical Technology.

Veopoz is also being investigated in other complement system-mediated diseases, including paroxysmal nocturnal haemoglobinuria (PNH) and myasthenia gravis. The combination therapy of Veopoz and Alnylam Pharmaceuticals’ cemdisiran, a small interfering RNAi C5 inhibitor, is being investigated in an open-label Phase II trial (NCT04888507).Veopoz

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