🏅 FDA Orphan Designation

Strensiq

ASFOTASE ALFA

Manufacturer: Alexion Pharmaceuticals, Inc.

Indicated for:

Perinatal lethal hypophosphatasiaChildhood-onset hypophosphatasia

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Black Box Warning (Boxed Warning)

A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.

View full prescribing information on DailyMed (NLM) ↗

FDA-Approved Indications (2)

Perinatal lethal hypophosphatasia

indicated for the treatment of patients with perinatal/infantile-onset hypophosphatasia (HPP)

Population: pediatric (perinatal/infantile)

Childhood-onset hypophosphatasia

indicated for the treatment of patients with juvenile-onset hypophosphatasia (HPP)

Population: pediatric (juvenile)

Indications & Usage

1 INDICATIONS AND USAGE STRENSIQ ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). STRENSIQ is a tissue nonspecific alkaline phosphatase indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). ( 1 )

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Strensiq

Alexion Pharmaceuticals, Inc.

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.