Pyrukynd Agios Netherlands B.V. · Authorised · authorised 9 Nov 2022 · ATC B06AX04
Therapeutic indication (EMA)
Pyrukynd is indicated for the treatment of pyruvate kinase deficiency (PK deficiency) in adult patients (see section 4.4).
Active substance
Mitapivat
- SFDA 1
- US FDA 2
- EMA 1
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Pyrukynd | 100 mg | Film-coated tablet · Oral use | 56 Blister | SAR 107301.35 | NCE · Prescription | Agios Pharmaceuticals | Valid |
US FDA United States — FDA approvals (Drugs@FDA)
EMA European Union — centrally authorised medicines
Safety signals and safety-related labeling changes
- US FDA 3 Jan 2025 PYRUKYND — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.