fizer and Boehringer Ingelheim have been boosted by the news that experts in the USA have recommended expanding the label on their chronic obstructive pulmonary disease blockbuster Spiriva.
The US Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee has voted 11 to 1 that clinical data included in a supplemental New Drug Application provide “substantial and convincing evidence” to support the claim that Spiriva (tiotropium) reduces exacerbations in patients with COPD. Interestingly, the panelists also voted that data from the four-year 6,000-patient UPLIFT trial “adequately addressed the potential safety concern for an increased risk of stroke (11 yes to one no) or adverse cardiovascular events (11 yes with one abstention).
In September 2008, claims were made in a meta-analysis published in the Journal of the American Medical Association that inhaled anticholinergics such as Spiriva and Boehringer’s older drug Atrovent (ipratropium) are associated with significantly increased risk of cardiovascular death, myocardial infarction or stroke.
The committee reviewed pivotal data from a six-month Veterans Affairs study of 1,829 COPD patients and secondary endpoints from UPLIFT which support data from the VA trial showing that Spiriva “consistently reduced the risk of exacerbations in COPD patients”. These were defined as sufferers having a new onset or worsening of symptoms (including cough, sputum, wheezing, or difficulty breathing) lasting for at least three days and which require a change in treatment (antibiotics or steroids), which could include hospitalisation.
Christopher Corsico, vice president of drug regulatory affairs at Boehringer’s US unit, said the firm is pleased with the advisory committee’s vote, adding that “exacerbations in COPD patients may lead to disability, premature death and increased healthcare costs”. He went on to say that the firm is looking forward to working with the FDA during the final stages of its review of the sNDA.
Getting an expanded label will help Pfizer and Boehringer promote Spiriva even more effectively against GlaxoSmithKline’s Advair/Seretide (salmeterol and fluticasone) for asthma and COPD which already has the exacerbation-reduction claim on its label.