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Naglazyme (galsulfase) – Conditions or restrictions regarding supply and use - A16AB

Updated on site: 08-Oct-2017

Medication nameNaglazyme
ATC CodeA16AB
Substancegalsulfase
ManufacturerBioMarin Europe Ltd.

AMANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

BioMarin Pharmaceutical Inc.

46 Galli Drive, Novato, CA 94949

United States of America

Name and address of the manufacturer responsible for batch release

Catalent UK Packaging Ltd

Wingates Industrial Park,

Westhoughton, Bolton,

Lancs, BL5 3XX

United Kingdom

BioMarin International Limited

Shanbally, Ringaskiddy

County Cork

Ireland

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

B CONDITIONS OF THE MARKETING AUTHORISATION

CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER

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

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

Not applicable.

OTHER CONDITIONS

The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.

An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management System for medicinal products for human use.

Pharmacovigilance system

The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation , is in place and functioning before and whilst the product is on the market.

Risk Management Plan

The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 002 of the Risk Management Plan (RMP) presented

in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.

As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).

In addition, an updated RMP should be submitted:

When new information is received that may impact on the current Safety Specification,Pharmacovigilance Plan or risk minimisation activities

Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached

At the request of the European Medicines Agency

PSURs

The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.

C.SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER

The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.

Specific Obligations:

Description:

Due Date

 

 

Module 5 – Clinical

 

SO2 001.3

Interim results will

To evaluate the long-term safety and efficacy data from Naglazyme treatment

be provided in the

a Clinical Surveillance Program (CSP) will be conducted.

CSP Annual

Substudies will be conducted within the CSP that will:

Reports.

1. Evaluate the effect of Naglazyme on pregnancy and lactation.

 

2. Evaluate the safety and efficacy of Naglazyme in 10 children less than

A brief update will

5 years of age will be treated with the 1 mg/kg dose for at least one year.

be submitted as part

Information will also be collected on clinical status, adverse events,

of the Annual

assessments of immunogenicity and potential effects on antibody formation.

Reassessments.

The CSP data will be analysed at yearly intervals and results will be submitted

 

as annual reports.

 

Detailed clinical status information will be collected at study entry and on an

 

annual basis for at least 15 years.

 

Other measures (urinary GAG, antibodies) are assessed more frequently.

 

Severe and serious liver toxicities will be assessed through the PSUR but also

 

through analysis of these events in the CSP database.

 

Subjects enrolled in the program will have urinary glycosaminoglycan and

 

samples for total antibodies routinely collected as specified in the Schedule of

 

Activities. Higher antibody levels (≥ 65610 Dilution Fraction) will be

 

compared with the subject’s urinary GAG values with a view to assess

 

potential impacts on efficacy. Samples from those subjects who have a

 

consistent increase in urinary GAG values together with high antibody levels

 

will have their antibody samples assessed for evidence of neutralizing

 

activities.

 

Samples for total antibody will be collected at specific intervals. If a physician

 

suspects an IgE mediated reaction they have been advised in the protocol to

 

request IgE antibody presence to be conducted by the MAH.

 

The final study report under this CSP will be submitted by 31 July 2020.

 

SOB 002

Final CSP Study

To evaluate the long-term safety and efficacy data from Naglazyme treatment

Report: 31 July

a Clinical Surveillance Program (CSP) will be conducted.

Substudies will be conducted within the CSP that will:

 

1. Evaluate the effect of Naglazyme on pregnancy and lactation.

 

2. Evaluate the safety and efficacy of Naglazyme in 10 children less than

 

5 years of age will be treated with the 1 mg/kg dose for at least one year.

 

Information will also be collected on clinical status, adverse events,

 

assessments of immunogenicity and potential effects on antibody formation

 

The CSP data will be analysed at yearly intervals and results will be submitted

 

as annual reports.

 

Detailed clinical status information will be collected at study entry and on an

 

annual basis for at least 15 years.

 

Other measures (urinary GAG, antibodies) are assessed more frequently.

 

Severe and serious liver toxicities will be assessed through the PSUR but also

 

through analysis of these events in the CSP database.

 

Subjects enrolled in the program will have urinary glycosaminoglycan and

 

samples for total antibodies routinely collected as specified in the Schedule of

 

Activities. Higher antibody levels (≥ 65610 Dilution Fraction) will be

 

compared with the subject’s urinary GAG values with a view to assess

 

potential impacts on efficacy. Samples from those subjects who have a

 

consistent increase in urinary GAG values together with high antibody levels

 

will have their antibody samples assessed for evidence of neutralizing

 

 

activities.

 

Samples for total antibody will be collected at specific intervals. If a physician

 

suspects an IgE mediated reaction they have been advised in the protocol to

 

request IgE antibody presence to be conducted by the MAH.

 

The final study report under this CSP will be submitted by 31 July 2020.

 

SO2 003.2

Interim results will

Several measures will be implemented to assess the Naglazyme dose. Data

be provided in the

collected in the post-marketing phase will also be examined to determine if a

annual

suitable Naglazyme maintenance dose can be recommended relative to the

re-assessment

efficacy endpoints used in the clinical studies.

reports.

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