AUTH/3354/5/20 - Complainant v Takeda

Date from which a medicine can be described as ‘new’

  • Received
    25 May 2020
  • Case number
  • Applicable Code year
  • Completed
    08 February 2021
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant who described him/herself as a concerned health professional, noted that an online advertisement for Takhzyro (lanadelumab) referred to the medicine as ‘new’ even though the marketing authorisation was granted over twelve months ago.

Takhzyro was indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

The detailed response from Takeda is given below.

The Panel noted that the Code required that the word ‘new’ must not be used to describe any product or presentation which had been generally available, or any therapeutic indication which had been promoted, for more than twelve months in the UK.

The Panel noted Takeda’s submission that Takhzyro was first authorised on 22 November 2018 and that the hosted webpage, which included the advertisement at issue, was the first promotional item published since 18 September 2019, the date Takeda considered Takhzyro to be ‘generally available’. Takeda had released a press release on 18 September 2019 about the outcome of the National Institute of Health and Care Excellence (NICE) appraisal process stating that the final appraisal document would recommend NHS funding for Takhzyro [a high-cost medicine] providing certain conditions were followed.

The Panel further noted Takeda’s submission that ‘general availability’ could otherwise be regarded as being the date of the first supply of commercial Takhzyro stock into the UK ie 26 June 2019; if funding was available, prescriptions could have been fulfilled from then on.

Whilst noting Takeda’s submissions about the product’s general availability, the Panel also noted Takeda’s submission about three presentations, one by a Takeda medical team member on 1 April 2019 and two by health professionals for which Takeda was responsible at a meeting on 2-3 May 2019. The Panel examined the presentations and noted that two presentations detailed the pivotal study; all three were clearly promotional and, as acknowledged by Takeda, had been certified as such.

In the Panel’s view, Takhzyro had been promoted from 1 April 2019 and thus could only be described as new for 12 months from that date. The Panel noted that the advertisement at issue which described Takhzyro as ‘a new preventative treatment for use in type I/II HAE’ appeared to have been viewed by the complainant towards the end of May 2020 when the complaint was submitted. The Panel therefore ruled a breach of the Code.