Spiriva partners defend drug’s safety
pharmafile | October 2, 2008 | News story | Sales and Marketing | Boehringer, COPD, Spiriva, resp
Boehringer Ingelheim and Pfizer have released new data on Spiriva to defend the safety record of the chronic obstructive pulmonary disease (COPD) treatment.
The move comes in response to a new meta-analysis study which claims anticholinergic medicines, including Spiriva, significantly increase risk of cardiovascular death, heart attack or stroke in patients with COPD.
Boehringer Ingelheim and Pfizer say their data contradicts this finding, and say COPD patients have a higher cardiovascular risk than the average population.
The companies have also highlighted shortcomings in the study, which is mainly based on ipratropium, or Atrovent, a predecessor drug to Spiriva.
The companies will fear a collapse in confidence among the medical community, which could produce a dramatic drop in Spiriva sales if regulators confirm safety concerns.
GSK's Avandia saw its sales fall rapidly in just a few months in 2007 after a similar independent review of data concluded it carried previously unnoticed cardiovascular safety risks.
Spiriva is a blockbuster drug with sales expected to hit more than $2.5 billion (1.8 billion euros) this year. Sales rose 24% in the first half of 2008 compared to the same period last year, with sales of 976 million euros.
Boehringer Ingelheim and Pfizer have released details of 30 clinical trials, saying they wanted to give doctors the fullest and most up-to-date safety information on Spiriva, which they say is absolutely safe.
"We strongly disagree with the conclusion reached by Singh et al," said Andreas Barner, vice chairman of the board of managing directors at Boehringer Ingelheim, responsible for research, development and medicine.
"We have disclosed to regulatory authorities worldwide this important information which is part of a very robust analysis of all our double-blind, placebo-controlled, parallel group trials with a duration of at least four weeks," he continued.
"Our analysis, which includes data from the four-year UPLIFT trial, supports the safety profile of Spiriva."
The Boehringer Ingelheim trials involved nearly 20,000 COPD patients and suggested there was no increased risk of death by all causes or death due to cardiovascular events in patients treated with Spiriva specifically. Nor was there an increased risk of stroke or heart attack.
The companies said peer-reviewed meta-analyses of aggregate published data such as in the JAMA article have "well-recognised limitations".
The reaction of regulators in the US and Europe will be of vital importance to the drug. Even before the new study was published, the FDA announced in March its own review of the Spiriva safety data. This was prompted by Boehringer Ingelheim informing the regulator that its own analysis of pooled data had shown a potential small raised risk of stroke in patients taking Spiriva.
Neither the FDA nor Europe's EMEA have responded to the new study as yet, which suggests the drug has already avoided the very worst safety scare.
The full results of the UPLIFT trial are to be presented this weekend at the European Respiratory Society 2008 Annual Congress in Berlin.
Related Content
Sanofi and Regeneron share results from phase 3 trial for Dupixent as COPD treatment
Sanofi and Regeneron have announced results from the second investigational phase 3 NOTUS trial for …
Verona Pharma submits FDA New Drug Application for COPD treatment
UK-based Verona Pharma has announced that it has submitted a New Drug Application (NDA) to …
European approval for AstraZeneca’s Trixeo Aerospace in moderate to severe COPD
The European Medicines Agency (EMA) has announced the approval of AstraZeneca’s Trixeo Aerosphere (formoterol fumarate/glycopyrronium …
