Notice: Multiple Additions to the Prescription Drug List (PDL) [2022-08-17]

Date: August 17, 2022
Our file number: 22-109195-425

The purpose of this Notice of Amendment is to notify about the additions of avacopan, berotralstat, capmatinib, faricimab, mogamulizumab, selinexor, tebentafusp, and ursodoxicoltaurine to the Prescription Drug List (PDL) for human and veterinary use.

The new medicinal ingredients will be added to the PDL as the following:
Drugs containing any of the following Including (but not limited to) Qualifier
Avacopan or its salts N/A N/A
Berotralstat or its salts N/A N/A
Capmatinib or its salts N/A N/A
Faricimab N/A N/A
Mogamulizumab N/A N/A
Selinexor or its salts N/A N/A
Tebentafusp N/A N/A
Ursodoxicoltaurine 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.

Albrioza (sodium phenylbutyrate/ursodoxicoltaurine) is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).

Kimmtrak (tebentafusp) is indicated for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Orladeyo (berotralstat) is indicated for the routine prevention of attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older.

Poteligeo (mogamulizumab for injection) is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

Tabrecta (capmatinib tablets) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

Tavneos (avacopan capsules) is indicated for the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard background therapy including glucocorticoids. Tavneos does not eliminate glucocorticoid use.

Vabysmo (faricimab injection) is indicated for the treatment of:

Xpovio (selinexor) is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

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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