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PMCPA Case

AUTH/2763/5/15: PMCPA Director v AstraZeneca (clinical trial disclosure – Caprelsa/Zinforo) – No breach

📅 2015 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2763/5/15
PartiesPMCPA Director v AstraZeneca
Case type / routeParagraph 5.1 (Director-initiated)
IssueClinical trial disclosure (timeliness/scope) for Caprelsa (vandetanib) and Zinforo (ceftaroline fosamil)
Source prompting complaintABPI-funded CMRO publication (online 5 May 2015) and its supplemental disclosure tables
Complaint received / proceedings commenced14 May 2015
Case completed2 July 2015
Applicable Code year (case listing)2008
Clauses consideredClause 2; Clause 9.1; Clause 21.3
Caprelsa data in paper41 evaluable; 39 disclosed within timeframe (95%); two Phase II trials flagged as undisclosed within timeframe
Caprelsa Panel reasoningTrials completed Nov 2003 and Aug 2006; 2008 Code/Joint Position 2005 applied; one pre-dated Joint Position 2005 and was published May 2005; the other was exploratory, terminated early, not medically significant and did not impact labelling
Zinforo data in paper10 evaluable; 7 disclosed within timeframe (70%); 9 disclosed by 31 July 2014 (90%); one remained undisclosed at 31 July 2014
Zinforo Panel reasoningTwo older studies completed July 2008/Feb 2009 were before AstraZeneca sublicence (responsibility of another company; separate case AUTH/2772/6/15). Remaining study NCT01298843 (completed Feb 2013) was sponsored/designed/conducted by Forest in the US with no UK involvement; AstraZeneca not responsible under UK Code; out of scope
AppealNo appeal
Final decisionNo breach of the Code

Download the full case report (PDF)

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

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  • An ABPI-funded paper in Current Medical Research & Opinion (published online 5 May 2015) assessed whether results of company-sponsored trials linked to new medicines approved by EMA in 2012 were disclosed within 12 months (or by 31 July 2014).
  • The PMCPA Deputy Director initiated a complaint under Paragraph 5.1 against AstraZeneca UK Limited based on the paper’s supplemental data.
  • The supplemental tables suggested some trials linked to two AstraZeneca products were not disclosed within the paper’s “timely” window:
    • Caprelsa (vandetanib): 41 evaluable trials; 39 disclosed within timeframe (95%). Two Phase II trials not disclosed within timeframe.
    • Zinforo (ceftaroline fosamil): 10 evaluable trials; 7 disclosed within timeframe (70%); 9/10 disclosed by 31 July 2014 (90%). One trial remained undisclosed at 31 July 2014.
  • AstraZeneca explained that the Caprelsa trials were exploratory Phase II studies completed in 2003 and 2006 and fell under the 2008 Code/Joint Position 2005 (with different expectations for exploratory trials and older studies).
  • For Zinforo, AstraZeneca explained that two older exploratory studies were conducted before AstraZeneca held the sublicence (responsibility lay with another company), and the remaining paediatric PK study was sponsored/designed/conducted by Forest Laboratories in the US with no UK involvement (AstraZeneca reimbursed half the cost for a paediatric investigation plan).
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Outcome

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  • No breach of the Code.
  • Caprelsa: No breach of Clause 21.3 of the 2008 Code; consequently no breach of Clauses 9.1 and 2.
  • Zinforo: Panel ruled the remaining undisclosed study was outside the scope of the UK Code due to no UK involvement and AstraZeneca not being responsible for disclosure under the ABPI Code; therefore no breach.
  • No appeal.
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