AstraZeneca’s triple therapy for chronic obstructive pulmonary disease (COPD), Breztri Aerosphere (budesonide+glycopyrrolate+formoterol fumarate), has been approved in the US following a rejection last year.
Approval follows a rejection by the FDA in October last year after the FDA refused to grant a licence based on findings of the KRONOS clinical trial and asked for further clinical data to support its filing.
AZ has since submitted data from its second phase 3 trial, ETHOS, allowing the FDA to approve.
The approval was based on the clinical data showing that Breztri outperformed AZ’s already marketed dual therapy Bevespi Aerosphere (glycopyrrolate+formoterol fumarate) and a combination of budesonide and formoterol fumarate.
FDA approval triggers a $150 million milestone payment under the terms of its agreement to buy Pearl Therapeutics in 2013, which was worth up to $1.15 billion.
Approval in the US was also supported by efficacy and safety data from the phase 3 KRONOS trial.
The deal, based on a $560 payment up front plus development milestones, added the main components of the double and triple therapies to AZ’s pipeline – a fixed-dose combination of the long-acting beta-2 agonist formoterol fumarate and glycopyrrolate.
Breztri Aerosphere is approved in Japan and China for patients with COPD and is under regulatory review in the EU. It is not indicated for relief of acute bronchospasm or asthma in the US or other countries.
The US respiratory diseases market is highly competitive after the FDA finally approved a generic of GSK’s blockbuster COPD and asthma drug Advair.
Sales of Advair had been propped up because the FDA has tough requirements for manufacturers who are trying to make generic copies of drug/device combinations.
This meant that Advair had not been directly challenged until last year even though its main patent expired in 2010, and the patent on the Diskus inhaler expired in 2015.
Aside from Advair generics GSK also markets Trelegy in COPD, and there are other potential competitors in the pharma pipeline.
Last week Verona Pharma raised $200 million in an oversubscribed private fundraiser, which will finance phase 3 development of its COPD drug ensifentrine.
This has a different dual mechanism of action, opening the airways and reducing inflammation in the lungs by inhibiting the enzymes phosphodiesterase 3 and 4.
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