Notice: Multiple additions to the Prescription Drug List (PDL) [2024-12-20]
December 20, 2024
Our file number: 24-111533-667
The purpose of this Notice of Amendment is to notify about the addition of avapritinib, exagamglogene autotemcel (human), ilunocitinib (veterinary), momelotinib, sotatercept, tarlatamab, and trofinetide to the Prescription Drug List (PDL) for human and/or veterinary use.
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Avapritinib or its salts | N/A | N/A |
| Momelotinib or its salts | N/A | N/A |
| Sotatercept | N/A | N/A |
| Tarlatamab | N/A | N/A |
| Trofinetide or its salts | N/A | N/A |
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Exagamglogene autotemcel | N/A | N/A |
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Ilunocitinib or its salts | N/A | N/A |
These additions are effective at the time of posting.
Rationale
A scientific review of these drugs against the criteria set out in C.01.040.3 of the Food and Drug Regulations indicates that these drugs require prescription status.
Ayvakyt (avapritinib tablets) is indicated for:
- the treatment of adult patients with advanced systemic mastocytosis (AdvSM). AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).
Casgevy (exagamglogene autotemcel) is an autologous genome edited hematopoietic stem cell‑based therapy indicated for the treatment of patients 12 years of age and older with:
- sickle cell disease (SCD) with recurrent vaso‑occlusive crises (VOCs); OR
- transfusion‑dependent β‑thalassemia (TDT)
Daybue (trofinetide oral solution) is indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older and weighing at least 9 kg.
Imdelltra (tarlatamab for injection) is indicated for:
- the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after at least two prior lines of therapy including platinum-based chemotherapy.
Ojjaara (momelotinib) is indicated for:
- the treatment of splenomegaly and/or disease-related symptoms, in adult patients with intermediate or high-risk primary myelofibrosis (MF), post polycythemia vera myelofibrosis or post essential thrombocythemia MF who have moderate to severe anemia.
Winrevair (sotatercept) is indicated:
- In combination with standard pulmonary arterial hypertension (PAH) therapy, for the treatment of adults with World Health Organization [WHO] Group 1 PAH and Functional Class (FC) II or III.
Zenrelia (ilunocitinib) is indicated for the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.
Should you have any questions regarding this notice, please contact:
Health Canada
Pharmaceutical Drugs Directorate
Bureau of Policy, Science and International Programs
Office of Science
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca
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