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PMCPA takes AZ to task over asthma drug press release

Concluded that the data in the release had not been “placed in context”


A complaint filed by GlaxoSmithKline against AstraZeneca about a press release for its severe asthma drug Fasenra, which competes with GSK’s Nucala, has been largely upheld by the industry governing body.

The source of GSK’s anger was a PR put out by AZ after interleukin-5 inhibitor Fasenra (benralizumab) was recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP) last November, which it claimed contained “unbalanced and misleading” statements on Fasenra’s clinical data and was effectively an advert for the drug.

The Prescription Medicines Code of Practice Authority (PMCPA), the UK pharmaceutical industry’s self-regulatory body, backed a number of GSK’s concerns but said overall that it “did not consider that the claim in the press release was an advertisement for Fasenra, a prescription only medicine, to the public”.

The spat comes as Fasenra and Nucala (mepolizumab) are slugging it out in the severe asthma category, with GSK’s drug firmly in the lead - thanks to a two-year lead in the market - with $344m ($457m) in sales last year.

In the complaint, GSK maintained that the statement that benralizumab cut the annual asthma exacerbation rate by up to 51% compared to placebo cherry-picked the best result out of two pivotal trials of the drug, as the other study achieved a 28% reduction.

It also took issue with claims relating to Fasenra’s speed of onset, convenience, its effects on oral corticosteroid (OCS) use, and its safety profile which AZ indicated was similar to placebo. Some of the claims related to these measures were promotional in nature and in breach of the PMCPA code, asserted GSK.

Taking into account AZ’s response, the PMCPA ruled that the 51% reduction statement was in breach, as were statements related to a “rapid improvement in lung function” seen with AZ’s drug that it said were misleading because the PR didn’t make it clear the changes were from baseline, and not a comparison with placebo.

Similar reasoning was used to uphold the complaint about OCS use, with the PMCPA panel concluding that the data in the release were “not placed in context” and so had not been presented in a balanced way. It also ruled that the statement about placebo-like AERs exaggerated the properties of Fasenra.

The two drugs’ dosing schedules is also a hot topic, and GSK asked the PMCPA to rule on AZ’s claim that Fasenra offered “convenience” to patients, which the drugmaker said related to an eight-week maintenance dosing schedule compared to four-week dosing with Nucala.

The watchdog said it was debatable whether that was more convenient “given AZ’s product had three doses at four week intervals”, but also said that the statement could be read as a comparison with inhaled asthma drugs or oral medications and was misleading.

Overall, the PMCPA noted the breaches but said that while they fell short of the “high standards” expected they did not constitute a clause 2 breach - which would indicate that it brought discredit to the industry.

Advisory board breach

Meanwhile, AZ was also been named in another PMCPA complaint - brought by an unidentified employee - that alleged breach of conduct relating to an advisory board run by the company in Amsterdam last November relating to SGLT2 inhibitor diabetes drugs and specifically its Forxiga (dapagliflozin) product.

The PMCPA concluded there were a number of issues with the meeting, including the number of AZ attendees, last-minute changes to the arrangements for the event (which were also submitted for review late in the day), and had not been properly certified.

That added up to a breach, but overall it concluded that it “did not consider that the complainant had shown, on the balance of probabilities, that the advisory board…failed to meet the requirements of the Code and thus that any payment was inappropriate”.

Article by
Phil Taylor

1st June 2018

From: Regulatory



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