aBLA Filing Intelligence & Biosimilar Opportunity

Pombiliti

Cipaglucosidase Alfa-Atga

Antimetabolic Disorder

IV Infusion

Pombiliti, used with Opfolda (miglustat), treats adults with late-onset Pompe disease who aren’t responding to enzyme replacement therapy. It delivers an enzyme to break down muscle-accumulated glycogen, improving muscle strength and lung function.

Approval Date

28-Sep-23

Data Exclusivity Expiry

28-Sep-27

Market Exclusivity Expiry

28-Sep-35

Commercial snapshot

Market performance & projections

Revenue ($M)

113

CAGR (%)

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

2027

2028

2029

2030

2031

2032

Molecule profile

Details & specifications

Molecule

Cipaglucosidase Alfa-Atga

Innovator

AMICUS THERAPEUTICS

Dosage Form

IV Infusion

Strength

105 mg/vial

Therapeutic Category

Antimetabolic Disorder

Usage

To treat late-onset Pompe disease

Good to know

Frequently asked questions

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