Notice: Multiple Additions to the Prescription Drug List (PDL) [2024-04-30]

April 30, 2024
Our file number: 24-103562-165

The purpose of this Notice of Amendment is to notify about the addition of capivasertib, etrasimod and olipudase alfa to the Prescription Drug List (PDL) for human and veterinary use.

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.

Truqap (capivasertib tablets), in combination with fulvestrant, is indicated for the treatment of adult females with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Velsipity (etrasimod) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or an advanced treatment.

Xenpozyme (olipudase alfa) is an enzyme replacement therapy indicated for:

• long-term treatment of non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in pediatric and adult patients.

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