Stiolto+ICS, its COPD pipeline expert Nicholas Gross supposed another triple might be in the works: After discovering that Boehringer is testing Stiolto vs. Therefore, it is now highly likely that single-inhaler triple combos will consolidate the current large share in the COPD segment.Īs a note aside, BI's commercial strategy evidently was not clear enough for the Journal of the COPD Foundation. In this trial, the LABA/LAMA/ICS combo Trelegy clearly demonstrated a huge exacerbation benefit compared to the LABA/LAMA Anoro, invalidating much of the arguments against ICS use. Hence the importance of GSK's IMPACT study. So BI is clearly trying to position Spiolto as the single most important therapy, similar to Spiriva's prior positioning. The uncomfortable situation of BI shows in its efforts to undermine the clinical rationale for triple therapy and culminated in its filing of a citizen petition against the approval of GSK's closed triple (which was apparently dismissed by the FDA).įor ERS 2017, BI presented an ambitious, 16,000 patients multi-trial program for its LABA/LAMA Spiolto and an anti-ICS infographic on its website: The future will likely see a continuation of this battle, probably between LABA/LAMA (where GSK now competes as well) and LABA/LAMA/ICS (where BI probably won't compete). So far, each had its own entry point: BI took over some patients with its LAMA Spiriva and GSK took the other part with its LABA/ICS Advair. An application for a corresponding label expansion has already been submitted to the FDA.īut why is this label expansion so important?įor many years there has been a battle between Boehringer Ingelheim and GSK, as both try to define the COPD patient journey. In IMPACT, Trelegy could reduce the annual rate of moderate and severe exacerbations by 15% compared to LABA/ICS and by a whopping 25% compared to LABA/LAMA (which had been thought to be the more difficult comparator). whether the triple could effectively demonstrate an exacerbation benefit compared to dual inhalers such as Anoro, Ultibro/n, St/Spiolto or Breo, Symbicort and Advair. Just a coincidence? - In this case it was an unfortunate one for GSK, as the study removed one of the most important concerns, i.e. Its absolutely impressive results were published exactly one day after Trelegy was approved in the U.S. And the drug is not even approved for asthma.Īnother factoid relates to the IMPACT study. Yet, the asthma-related death warning is still on Trelegy's label. label effectively restricts prescribing to those patients that are already on one or more of Trelegy's components, but with insufficient results.Įven stranger is the boxed warning, as the FDA itself stated in December that its own review did not find a significant increase in risk of serious asthma outcomes with long-acting beta agonists used in combination with inhaled corticosteroids. While the EU label allows broad use instead of LABA/ICS medications (such as Advair, Breo, Symbicort), the U.S. The drug was approved for COPD much earlier than expected both in the EU and in the U.S., albeit with very different labels. However, GSK considers Trelegy to be one of its most important products going forward. We also learnt that Trelegy was effectively not included in the mystery bunch of new products with which GSK in 2015 predicted to rake in a total of GBP 6B in annual sales by 2020. GSK expects a more rapid uptake following the sNDA approval. In the meantime, the company is working on getting coverage in place and winning over pulmonologists. The most important news was that GSK is foreseeing a relatively slow ramp before the expected label expansion (inclusion of exacerbation benefit - see below) later this year. Today we finally learnt how much it sold in its first few weeks, but as the drug was launched late in Q4, the data wasn't really indicative of anything. ![]() And even now, that the long-awaited Trelegy Ellipta is finally on the shelves, there is no clarity. When I started to investigate GlaxoSmithKline's ( NYSE: GSK) then future triple combo for COPD, I would never have thought it could be such a controversial story. If you go beyond taking for granted nicely spun company communications, it's easy to get lost. Sometimes security research is really like an abstract painting.
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