Regulatory Decision Summary for Adynovate

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Medicinal ingredient(s):

Antihemophilic Factor (Recombinant), PEGylated

Therapeutic area:

Antihaemorrhagic Blood Coagulation Factor VIII

Type of submission:

Supplement to a New Drug Submission

Control number:

231976
What was the purpose of this submission?

 

ADYNOVATE was approved in Canada for the 250, 500, 1000, and 2000 IU/Vial strengths reconstituted with a 5 mL sterile water for injection (sWFI) diluent. This submission was seeking approval for:

  • a new 2 mL diluent with the approved 250 IU, 500 IU, and 1000 IU strengths;
  • a new 750 IU strength with both 2 and 5 mL diluent, and;
  • a new 1500 IU strength with both 2 and 5 mL diluent, and;
  • a new 3000 IU strength with the 5 mL diluent.

A Notice of Compliance (NOC) was recommended and issued.

 

Why was the decision issued?

 

This submission proposed the introduction of three new presentations for ADYNOVATE 750, 1500, and 3000 IU/vial as well a new 2mL sWFI diluent to be used with the 250 to 1500 IU presentations.

This was primarily a Quality (Chemistry and Manufacturing) related submission and the clinical review was limited to consultation on the Product Monograph. Quality elements provided for review demonstrated the capacity of the sponsor to consistently manufacture product comparable to that used in the original clinical studies supporting ADYNOVATE.

The sponsor provided a rationale for omission of dedicated clinical studies for the new formats and a clinical waiver was granted.

In their rationale, the sponsor indicated that additional clinical trials were not warranted as:

  • The final excipient concentrations of the drug product and patient dosing has not changed;
  • The route of administration has not changed;
  • No new safety signals were observed as increased nominal concentrations were marketed in US and Australia;
  • Reconstitution with a smaller volume had no clinical impact for the related product ADVATE (ADYNOVATE is a PEGylated form of ADVATE).

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.

Date of decision:

2020-05-01

Manufacturer:

Shire Pharma Canada ULC

Drug Identification Numbers issued:

  • DIN 02498537 - IV, PWSO, 250 IU / vial, 2 mL diluent
  • DIN 02498545 - IV, PWSO, 500 IU / vial, 2 mL diluent
  • DIN 02498553 - IV, PWSO, 750 IU / vial, 2 mL diluent
  • DIN 02498588 - IV, PWSO, 1000 IU / vial, 2 mL diluent
  • DIN 02498596 - IV, PWSO, 1500 IU / vial, 2 mL diluent
  • DIN 02498561 - IV, PWSO, 750 IU / vial, 5 mL diluent
  • DIN 02498618 - IV, PWSO, 1500 IU / vial, 5 mL diluent
  • DIN 02498626 - IV, PWSO, 3000 IU / vial, 5 mL diluent

Prescription status:

Schedule D drug

Date filed:

2019-09-30

Contact:

Office of Regulatory Affairs - Biologic and Radiopharmaceutical Drugs Directorate (ORA-BRDD)
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