To: Head of Paediatric Medicines European Medicines Agency 30 Churchill Place London E14 5EU United Kingdom [email protected] Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision Actives substances(s): Anti proprotein convertase subtilisin kexin type 9 humanized monoclonal antibody (PF-04950615) Invented name:

CLERAMARC

Latest Decision number(s):

1) P/0080/2014

2) P/

Corresponding PIP number(s): 1) EMEA-001430-PIP01-13

3) P/ 2) EMEA-

4) P/ 3) EMEA-

4)

EMEAPlease note that development of the medicinal product above in the [condition(s)/indication(s)]: Condition: Treatment of elevated cholesterol (Indication - Treatment of heterozygous or homozygous familial hypercholesterolaemia.

090177e18aa778b3\Final\Final On: 22-Nov-2016 14:47

Condition: Treatment of mixed dyslipidaemia Condition: Prevention of cardiovascular events in patients with cardiovascular disease or cardiovascular disease risk equivalent. has been discontinued has been suspended/put on long-term hold (with possible re-start at a later time) for the following reason(s): (tick all that apply) (possible) lack of efficacy in adults (possible) lack of efficacy in children (possible) unsatisfactory safety profile in adults (possible) unsatisfactory safety profile in children commercial reasons (please specify: Pfizer has determined that the product profile for bococizumab is not likely to provide value for patients or physicians.) manufacturing / quality problems other regulatory action

(please specify:

) (e.g. suspension, revocation of M.A.)

other reason

(please specify:

)

Please add a brief description (max 2000 characters) of the reason(s) for the discontinuation / suspension: The purpose of this submission is to inform the Agency that Pfizer has decided to discontinue the global clinical development program for bococizumab. This decision was not based on a recommendation by the independent Data Monitoring Committee to stop the program. Rather, after careful consideration, in light of the emerging clinical profile of bococizumab and evolving treatment

landscape for lipid-lowering agents, Pfizer has determined that the product profile for bococizumab is not likely to provide value for patients or physicians.

Name and signature of the PIP contact point:

090177e18aa778b3\Final\Final On: 22-Nov-2016 14:47

Date:

Signature on file 16Nov2016

Contact for inquiries from interested parties:

PIP Enquiries

Telephone:

+44 (0)1304 646607

Email:

[email protected]

PF-04950615 - European Medicines Agency - Europa EU

Notification of discontinuation of a paediatric development which is covered by an agreed ... for the following reason(s): (tick all that apply). (possible) lack of ...

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