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Kanuma (sebelipase alfa) – Conditions or restrictions regarding supply and use - A16

Updated on site: 08-Oct-2017

Medication nameKanuma
ATC CodeA16
Substancesebelipase alfa
ManufacturerAlexion Europe SAS

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

Fujifilm Diosynth Biotechnologies USA Inc 6051 George Watts Hill Drive

Research Triangle Park North Carolina

NC 27709 UNITED STATES

Name and address of the manufacturer responsible for batch release

Almac Pharma Services Ltd. Seagoe Industrial Estate Craigavon

Co Armagh

BT63 5UA United Kingdom

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic safety update reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

At the request of the European Medicines Agency;

Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or

as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

Additional risk minimisation measures

Prior to launch of Kanuma in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational material including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.

The educational material is aimed to encourage healthcare professionals to enrol patients in the prospective disease and clinical outcome registry of patients with Lysosomal Acid Lipase (LAL) Deficiency to monitor for efficacy and safety of Kanuma (LAL Deficiency Registry), with particular regard to hypersensitivity reactions, including anaphylaxis, and anti-drug antibodies (ADA) development impacting response to drug.

The MAH shall ensure that in each Member State where Kanuma is marketed, all healthcare professionals who are expected to use Kanuma have access to the educational material. The educational material should contain:

Summary of Product Characteristics

Guide for healthcare professionals

The Guide for healthcare professionals shall contain the following key elements:

Warning and precautions on the the risk of hypersensitivity including anaphylaxis or ADA development, with particular reference to symptoms, time to onset and severity.

Information on how to manage patients experiencing severe hypersensitivity reactions including anaphylaxis.

Details on how to monitor for potential ADA formation following initiation of treatment with Kanuma, particularly in patients on Kanuma who experience clinically important hypersensitivity reactions or potential loss of clinical response.

Information to healthcare professionals that it is the responsibility of the MAH to provide the test for the monitoring of ADA positive patients including the modalities for requesting the test.

Information on the ongoing LAL Deficiency Registry, including the importance of enrolling patients, also those not treated with Kanuma, and the modalities for participation.

Obligation to conduct post-authorisation measures

The MAH shall complete, the measures described below:

Description

Due date

Non-interventional post-authorisation safety study (PASS): LAL Deficiency

Interim reports

Registry: Non-interventional, multicentre, prospective disease and clinical

expected yearly

outcome registry of patients with Lysosomal Acid Lipase Deficiency to further

within PSURs

understand the disease, its progression and any associated complication, and to

 

evaluate the long-term efficacy (normalisation of hepatic function) and safety

Final study

of Kanuma (in particular hypersensitivity reactions, including anaphylaxis, and

report expected

anti-drug antibodies development potentially impacting response to drug)

in Jan 2027

according to agreed protocol.

 

Study LAL-CL08: an open-label, Phase 2 study in infants with rapidly

Final study

progressive LAL Deficiency to explore long-term safety and efficacy data. The

report expected

efficacy objectives are assessment of hepatic function overtime up to 3 years

in December

and survival at 12 months. The safety objectives should focus on

hypersensitivity reactions, particularly anti-drug antibodies development

 

impacting response to drug.

 

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