- The Food and Drug Administration rejected AstraZeneca's triple combination inhaler PT010 for chronic obstructive pulmonary disease (COPD), which has already received approval in Japan as Breztri Aerosphere.
- The British-based big pharma did not state why the FDA sent a Complete Response Letter, but said it plans on giving regulators the results from the ETHOS trial, which had not been completed at the time it formally asked for PT010's approval.
- In 2017, AstraZeneca's U.K. rival GlaxoSmithKline launched a triple COPD therapy called Trelegy Ellipta, which had 156 million pounds in sales ($200 million) last year and looks on track to clear $500 million in 2019.
Respiratory disease is a competitive market for drugmakers as older products lose market exclusivity and newer products need to show that they offer a substantial benefit over generics.
COPD patients, who often develop the condition after exposure to tobacco smoke or environmental pollutants, or have asthma that goes untreated, can improve their breathing and prevent flare-ups with treatments such as Advair (fluticasone propionate/salmeterol). The GSK drug is a combination of a steroid and a type of medication called a long-acting beta2-adrenergic agonist, which now faces direct competition in the U.S. from Mylan's Wixela Inhub.
The big drugmakers have attempted to extend their respiratory franchise by adding a third type of medication called an anticholinergic, arguing that the addition of an agent that some patients were already using separately could improve treatment adherence and prevent flare-ups. GSK's Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is one example of these three-drug regimens.
AstraZeneca's entry, named PT010, combines the ingredients of its drug Symbicort (budesonide/formoterol fumarate), which doesn't yet face a generic competitor, with an anticholinergic called glycopyrronium.
The FDA's rejection of PT010 sets back the company's efforts to compete with GSK in the so-called closed triple market until 2020 at the earliest.
In asking the FDA for approval, AstraZeneca submitted the results of the Phase 3 KRONOS trial, which showed that, when compared to the dual drug Bevespi Aerosphere (glycopyrrolate/formoterol fumarate), treatment with PT010 improved lung function. PT010 did not, however, reduce the number of flare-ups — called "exacerbations" — that can land COPD patients in the hospital.
ETHOS, which read out at the end of August, has shown a statistically significant reduction in exacerbations when compared to Bevespi, although the magnitude of that reduction has not been disclosed.
Trelegy showed a statistically significant 15% and 25% reduction in COPD patients' exacerbation rates when compared to dual therapies. Patients taking Trelegy on average had 0.91 exacerbations per year, compared with 1.07 for patients taking Breo Ellipta (fluticasone furoate/vilanterol) and 1.21 for patients taking Anoro Ellipta (umeclidinium bromide/vilanterol).