Strensiq asfotase alfa

Drug Class

Tissue non-specific alkaline phosphatase replacement therapy

Mechanism

Replaces deficient tissue non-specific alkaline phosphatase (TNSALP), preventing inorganic pyrophosphate accumulation and promoting bone mineralization.

Approved Indication

Treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).

What This Means For Patients

Strensiq is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2015) — Sources
• EMA — Approved (2015) — Sources

Pivotal Clinical Evidence

• ENB-002-08/ENB-003-08 — Whyte et al., N Engl J Med 2012 (NCT01176266) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125513s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/strensiq