GSK double complaint ruled out by PMCPA
pharmafile | January 16, 2015 | News story | Medical Communications, Sales and Marketing | ABPI, COPD, GSK, PMCPA, Relvar, Seretide
Complaints questioning the promotion of two of GlaxoSmithKline’s chronic obstructive pulmonary disease (COPD) drugs have been ruled out by a PMCPA panel.
One objection accuses the UK pharma firm of trying to hide important safety information about Relvar (fluticasone furoate/vilanterol). The complainant argued that it is not made clear in any GSK marketing that the inhaler can cause pneumonia to asthma patients.
The other regards Seretide (salmeterol/fluticasone) and notes that the TORCH study – of which the device was trialled in – did not meet its primary endpoint. Despite this, promotional claims for Seretide have referred to favourable findings.
As the ruling and regulatory arm of the ABPI, the PMCPA concluded that not all marketing material for the treatment referenced secondary endpoint data from the study. But that high standards had not been maintained so a breach of Clause 9.1 – failing to maintain high standards at all times – was ruled, Clause 2 – discredit to the pharma industry – wasn’t.
The panel’s governing on Relvar concluded that information on pneumonia as a side-effect in patients with asthma is available, so did not warrant a breach of any clauses to the code. The information appears in the relevant sections of the company’s website, along with links to the Summary of Product Characteristics (SPC).
Both decisions will provide great relief to the British pharma firm which in 2012 was not so lucky, as it breached three clauses in the ABPI Code of Practice following a complaint from a member of its own staff.
GSK was found guilty of Clause 15.2 which deals with reps’ ethical conduct, after the employee protested that a representative had promoted the unlicensed use of blood disorder drug Revolade (eltromopag).
The complaint stemmed from an email sent referencing an individual funding request (IFR) for a patient. As a result the firm also breached Clauses 9.1 and 3.2, which states that the promotion of a medicine must be in accordance with the terms of its marketing authorisation.
However, the positive result from the PMCPA today for Relvar and Seretide mean that GSK can focus on the latter’s partial successor – Anoro (umeclidinium/vilanterol) – as it looks to compete in a market host to more than 21 million COPD patients.
Backed by the Committee for Medicinal Products for Human Use (CHMP) last year and given the nod in Europe just days later, the pharma firm’s new treatment – in partnership with biopharma Theravance – could generate worldwide annual sales of around $2.65 billion by 2019 according to Reuters.
Tom Robinson
Related Content
GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis
GSK’s Exdensur (depemokimab), a twice-yearly biological medicine, has received approval from the UK Medicines and …
Multiple myeloma treatment approved in Japan
GSK’s Blenrep (belantamab mafodotin) combinations have been approved by Japan’s Ministry of Health, Labour and …
Dupixent approved as first biologic medicine in Japan for COPD patients
The Ministry of Health, Labour and Welfare in Japan has authorised marketing and manufacturing of …
