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Strensiq (asfotase alfa) – Conditions or restrictions regarding supply and use - A16AB

Updated on site: 10-Oct-2017

Medication nameStrensiq
ATC CodeA16AB
Substanceasfotase 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

Lonza Biologics

101 International Drive

Pease International Tradeport

03801 Portsmouth

United States

Name and address of the manufacturer responsible for batch release

Alexion Pharma International Operations Unlimited Company

College Business and Technology Park, Blanchardstown

Dublin 15

Ireland

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.

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

Authority.

The educational programme is aimed to provide instruction to patients and carers for proper administration techniques to address the risks of medication errors and injection site reactions.

The MAH shall ensure that in each Member State where Strensiq is marketed all patients/parents or caregivers who are expected to use Strensiq are provided with the following educational package:

Patient information leaflet

Self-injection guide for patients

Injection guide for parents or caregivers with infant patients

The Patient/parents or caregivers guides shall contain the following key messages:

Warning and precautions on the potential risk of medication errors and injection site reactions associated with the use of Strensiq

Hypersensitivity reactions have been observed in patients treated with Strensiq, including a description of sign and symptoms;

Instructions on the correct dose to be administered

Instruction on how the injection site is chosen and how the injection is carried out and recorded

Detailed description on how Strensiq is injected using aseptic techniques

Information on cold chain management for Strensiq during storage and travel

Information on reporting side effect

Obligation to conduct post-authorisation measures

The MAH shall complete, within the stated timeframe, the below measures:

Description

Due date

The MAH should conduct a multicentre, randomized, open-label, Phase 2a study of

31 March 2018

Strensiq in patients with hypophosphatasia (HPP) to:

 

(i) evaluate pharmacokinetics (PK) of Strensiq in adults following administration of the

 

dose advised in children;

 

(ii) provide dose response data on plasma inorganic pyrophosphate (PPi) and pyridoxal-

 

5` -phosphate (PLP) and to explore evidence of clinical benefit.

 

In order to ensure that the data are reliable, the MAH should submit a study protocol

 

including acceptable techniques for blood collection, storage and assay for the PPi and

 

PLP biomarkers, to be agreed by CHMP before the start of the study.

 

The MAH should extend the studies ENB-008-10 and ENB-009-10 to provide efficacy

31 March 2017

data (such as, but not limited to RGI-C scores, height and weight change, biomarkers

 

measurement) in patients 13 to 18 year-old of age.

 

E.SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES

This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:

Description

Due date

The MAH should set up an observational, longitudinal, prospective, long-term registry of

Annually within

patients with HPP to collect information on the epidemiology of the disease, including

annual

clinical outcomes and quality of life, and to evaluate safety and effectiveness data in

reassessment

patients treated with Strensiq.

 

 

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