To: Head of Paediatric Medicines European Medicines Agency 30 Churchill Place London E14 SEU United Kingdom [email protected] Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision

Actives substances(s): Monoclonal IgGl Invented name:

Not Applicable

Latest Decision number(s):

1) P/0300/2016

2) P/

Corresponding PIP number(s): 1) EMEA-001831-PIP0l-15 EMEA-

4) P /

3) P/ 2) EMEA-

3) EMEA-

4)

Please note that development of the medicinal product above in the [condition(s)/indication(s)]: Treatment of influenza � has been discontinued

D 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

D (possible) lack of efficacy in children D (possible) unsatisfactory safety profile in adults D (possible) unsatisfactory safety profile in children D commercial reasons (please specify: ) D manufacturing/ quality problems (please specify: D other regulatory action D other reason (please specify:

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

Please add a brief description (max 2000 characters) of the reason(s) for the discontinuation/ suspension: The decision to terminate development occurred following an interim analysis of Phase 2b study in adult patients hospitalised with severe influenza. Primary and key secondary endpoints did not support a clinical benefit in this patient population. SAEs were numerically higher in the treatment + oseltamivir arm compared with oseltamivlr alone. The nature and pattern of SAEs was consistent with what might expected in this population, and did not suggest a clear drug-related cause. Name and signature of the PIP contact point:

Signature on file

Date:

16/02/18

Contact for inquiries from interested parties:

[email protected]

Telephone:

+41 616879411

Email:

[email protected]

Notification of discontinuation of a paediatric dev - European ...

oseltamivir arm compared with oseltamivlr alone. The nature and pattern of SAEs was consistent with what might expected in this population, and did not suggest a clear drug-related cause. Name and signature of the PIP contact point: Date: 16/02/18. Contact for inquiries from interested parties: [email protected]com.

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