European regulators back Chiesi COPD triple therapy

Chiesi’s COPD triple therapy has been given the green light by European regulators, paving the way for a new contender in a crowded market.

There is already a raft of drugs approved in chronic obstructive pulmonary disease (COPD), but the condition remains a challenge to treat and no-one has yet found a way to reverse the steady decline in lung function.

For years COPD symptoms were managed with drugs such as GlaxoSmithKline’s Seretide (salmeterol+fluticasone), combining an inhaled corticosteroid and a long-acting  beta2 agonist.

GSK has produced a new generation of COPD drugs to offset falling sales of Seretide – and a host of other companies are developing competitors too.

Boehringer Ingelheim’s Spiolto Respimat (tiotropium+olodaterol) is approved in Europe for COPD maintenance, as is Novartis’ Ultibro Breezhaler (indacaterol+glycopyronnium).

AstraZeneca’s Bevespi Aerosphere (glycopyrrolate+formoterol) has been approved in the US for COPD maintenance, and the company is in phase 3 development of an injected drug, benralizumab, to treat symptoms.

GSK’s own competing COPD triple therapy, developed in partnership with Innoviva, is also under review in Europe.

Chiesi will attempt to take on these newcomers with its triple therapy, which will be known as Trimbow.

Trimbow is an extra-fine fixed triple combination of an ICS, LABA, and long-acting muscarinic antagonist (LAMA) - containing beclomethasone dipropionate, formoterol fumarate and glycopyrronium bromide.

Europe’s CHMP scientific committee backed it on the basis of 12 trials involving more than 7,000 patients, including a favourable comparison with Seretide and another trial comparing it with Boehringer’s Spiriva (tiotropium) in COPD.

As many patients on maintenance therapies take an ICS/LABA combination, and an additional puff on a LAMA inhaler, Trimbow will represent a more convenient therapy in the likely event of approval by the European Commission.

Paolo Chiesi, Chiesi group vice president and head of R&D, said: “COPD affects millions of people across Europe, and Chiesi is committed to developing new therapeutic options that could help these patients' adherence to the therapy, thus reducing the risk of exacerbations and improving their quality of life.

"With this goal in mind, Chiesi has also developed the first fixed-dose ICS/LABA/LAMA triple combination."

While it looks like Chiesi could get the advantage of getting its drug to market first, whether it could compete against the might of GSK's rival, should it also get approval, remains to be seen.