Committee votes 15 to 1 in favour despite cancer concerns
Boehringer Ingelheim has taken a step closer to getting its chronic obstructive pulmonary disorder (COPD) olodaterol onto the US market, after an FDA advisory committee voted 15 to 1 in favour of its approval.
The agency's Pulmonary-Allergy Drugs Advisory Committee (PADAC) said Boehringer had provided “convincing” evidence to support the approval of olodaterol as a once-daily maintenance bronchodilator treatment for COPD.
The panel backed the efficacy and safety of the long-acting beta agonist (LABA), although some committee members raised questions about cases of cancer which were observed among patients who received it in clinical trials.
All told, 19 patients taking olodaterol at a 10mcg dose developed tumours, with 14 cases among those taking 5mcg and nine among those on placebo. As a precaution the panel recommended that Boehringer undertake post-marketing studies to monitor people taking the drug.
If approved by the FDA, the German pharma company hopes to sell the drug as Striverdi Respimat in the USA.
In trials, olodaterol delivered once daily at a 5mcg dose delivered improvements in lung function, as measured by forced expiratory volume in one second (FEV1), in patients with moderate to very severe COPD compared to placebo and also active comparators.
Boehringer is also is studying a once-daily combination of olodaterol and tiotropium, the active ingredient in Boehringer and Pfizer's Spiriva, which was approved in 2004 and along with GlaxoSmithKline's (GSK) $8bn product Advair/Seretide (fluticasone and salmeterol), is a dominant force in the COPD market with sales of around $5bn a year.
Other COPD combinations coming through development include Novartis' QVA149 (glycopyrronium bromide and indacaterol maleate), GSK and Theravance's Anoro (umeclidinium bromide and vilanterol), both of which are expected to reach the market later this year, and Forest Labs/Almirall's aclidinium bromide/formoterol candidate, which is in phase III.
Forest launched aclidinium bromide as a monotherapy in the US under the Tudorza brand name towards the end of last year.