Notice: Multiple additions to the Prescription Drug List (PDL) [2024-02-28]

February 28, 2024
Our file number: 24-101144 - 694

The purpose of this Notice of Amendment is to notify about the addition of elranatamab, epcoritamab, etranacogene dezaparvovec, fidanacogene elaparvovec, inebilizumab, landiolol, metreleptin, rimegepant and ritlecitinib to the Prescription Drug List (PDL) for human and veterinary use.

New medicinal ingredients to be added to the human and veterinary parts of the PDL

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.

Beqvez (fidanacogene elaparvovec) is an adeno-associated viral (AAV) vector-based gene therapy indicated for the treatment of adults (aged 18 years or older) with moderately severe to severe Hemophilia B (congenital Factor IX deficiency) who are negative for neutralizing antibodies to variant AAV serotype Rh74.

Elrexfio (elranatamab injection) is a B-cell maturation antigen (BCMA)-directed and CD3-directed bispecific antibody indicated as monotherapy for:

• the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Epkinly (epcoritamab injection / epcoritamab for injection) is indicated for:

• the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, DLBCL transformed from indolent lymphoma, high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL) or follicular lymphoma Grade 3B (FLG3b) after two or more lines of systemic therapy and who have previously received or are unable to receive CAR-T cell therapy.

Hemgenix (etranacogene dezaparvovec) is indicated for treatment of adults (aged 18 years of age or older) with Hemophilia B (congenital Factor IX deficiency) who require routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Litfulo (ritlecitinib) is indicated for:

• the treatment of adults and adolescents 12 years and older with severe alopecia areata.

Myalepta (metreleptin for injection) is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients:

• with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above.
• with confirmed familial partial LD (PL) or acquired PL (Barraquer-Simons syndrome), in adults and children 12 years of age and above with persistent significant metabolic disease for whom standard treatments have failed to achieve adequate metabolic control.

Nurtec odt (rimegepant orally disintegrating tablets) is indicated for:

• Acute treatment of migraine with or without aura in adults.

Sibboran (landiolol hydrochloride) is indicated for:

• The short-term reduction of ventricular rate in patients with supraventricular tachycardia including atrial fibrillation and atrial flutter in perioperative, postoperative, or other acute circumstances where short-term control of the ventricular rate with a short acting agent is desirable.

Uplizna (inebilizumab for injection) is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.

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