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Reblozyl

7 September 2021

The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.

Australian prescription medicine decision summary

Summary of submission

Submission type
New chemical entity
Product name
Reblozyl
Active ingredients
Luspatercept
ATC codes
B03XA06
Decision
Approved
Date of decision
27 August 2021
Date of entry onto ARTG
30 August 2021
ARTG numbers
334510 and 334511
Black Triangle Scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
Sponsor
Celgene Pty Limited
Sponsor address
Level 15, 60 City Road, Southbank VIC 3006
Dose forms

Powder for injection

Strength
50 mg/mL
Other ingredients
Citric acid monohydrate, sodium citrate dihydrate, polysorbate 80, sucrose, hydrochloric acid and sodium hydroxide
Containers
Vial
Pack sizes
One
Routes of administration
Subcutaneous injection
Dosage

Dosage of Reblozyl is based on multiple factors, including the condition being treated and the haemoglobin level of the patient.

For further information refer to the Product Information.

Pregnancy category

D
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.

What was approved?

Reblozyl luspatercept was approved for the following therapeutic use:

Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia (requiring 2 or more RBC units over 8 weeks) due to very low, low and intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS).

Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia associated with beta thalassaemia.

Limitation of Use

Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anaemia.

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

  • Reblozyl (luspatercept) is to be included in the Black Triangle Scheme. The Product Information and Consumer Medicines Information for Reblozyl must include the black triangle symbol and mandatory accompanying text for 5 years, which starts from the date that the sponsor notifies the TGA of supply of the product.
  • The Reblozyl European Union-Risk Management Plan (RMP) (version 1.0, dated 12 May 2020, data lock point May 2018), with Australian Specific Annex (version 2.0, dated 14 December 2020), included with submission PM-2020-01706-1-6, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
    An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
    Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than 3 years from the date of the approval letter.
    The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency’s Guideline on good pharmacovigilance practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.
  • Laboratory testing & compliance with Certified Product Details
    i. All batches of 334510 Reblozyl (luspatercept) 25 mg powder for injection vial and 334511 Reblozyl (luspatercept) 75 mg powder for injection vial supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
    ii. When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results http://www.tga.gov.au/ws-labs-index and periodically in testing reports on the TGA website.
    Certified Product Details
    The Certified Product Details, as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) (http://www.tga.gov.au/industry/pm-argpm-guidance-7...), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.