Boehringer complaint ruled out by PMCPA
A complaint made by a pharmacist stating that the artwork image for Boehringer Ingelheim’s COPD drug Striverdi is misleading has been ruled out by a PMCPA panel.
The criticism cites that the illustration of a middle-aged female cycling on her bicycle does not truly reflect the likely event of Striverdi Respimat (olodaterol) in patients with chronic obstructive pulmonary disease (COPD).
The ruling and regulatory industry arm of the ABPI concluded that given Striverdi is targeted at people with the mildest forms of COPD, no breaches of Clause 7.8 of the Code were made, citing that the artwork is not misleading as alleged.
The complainant referred to the section of the Code of Practice which states that care must be taken to ensure artwork does not mislead as to the nature of a medicine or any claim or comparison. The German-based pharma firm maintain that the image was supported by clinical data.
The PMCPA panel noted that the ruling was made due to data provided by Boehringer, including that 36% of patients would be classified in the mildest COPD category of which Striverdi caters for.
This decision will provide a great relief to the pharma giant which only last year invested more than €100 million into its Dortmund site in order to expand production capacity of its inhaler product. The move created 100 new jobs giving the firm the manpower to ratchet up units of the device to 44 million per year.
The positive result from the PMCPA for Striverdi also means that its business as usual for Boehringer, as it battles it out in a tough market competing with the likes of AstraZeneca’s COPD drug Symbicort plus GlaxoSmithKline’s $8 billion Advair sales.
Furthermore Citigroup analysts estimate that the COPD market is likely to increase from $10 billion in 2013 to $14 billion by 2018.
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