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AstraZeneca's Triple-Combo COPD Inhaler Gets CRL From FDA

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AstraZeneca plc AZN announced that the FDA has given a complete response letter to its new drug application (NDA) looking for approval of its investigational triple combination therapy, PT010 for chronic obstructive pulmonary disease (COPD).

PT010 is a combination of budesonide, an ICS with glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-agonists (LABA) therapy. PT010 can be delivered using AstraZeneca’s Aerosphere Delivery Technology.

Japan’s Ministry of Health, Labour and Welfare approved PT010 in June by the trade name of Breztri Aerosphere to relieve symptoms of COPD. The candidate is also under review in the EU and China.

The NDA was based on data from the KRONOS study, which compared PT010 to AstraZeneca’s own dual-combination therapies — Bevespi Aerosphere, Symbicort Turbuhaler, and PT009 — in COPD indication. AstraZeneca said that it will meet with the FDA to discuss the next steps including submission of data from another study — ETHOS — on PT010 for review. ETHOS data was not included in the NDA as the study was incomplete at that time. Last month, AstraZeneca announced that the ETHOS study, which evaluated PT010 in patients with moderate-to-very-severe COPD, met the primary endpoint. In the study, Breztri Aerosphere showed a statistically-significant reduction in the rate of moderate or severe exacerbations — the primary endpoint — at both standard and low budesonide doses compared with Bevespi and PT009 in the abovementioned COPD patients who have had a history of exacerbation(s) in the previous year.

We remind investors that Glaxo GSK also markets a once-daily, single inhaler triple combination therapy, Trelegy Ellipta for COPD. Trelegy Ellipta is a combination of fluticasone furoate — an ICS, umeclidinium — a LAMA and vilanterol — a LABA therapy. Trelegy Ellipta is delivered in Glaxo’s Ellipta dry powder inhaler. Theravance Biopharma, Inc. TBPH has an economic interest in Trelegy Ellipta and earns royalties on its sales.

In a separate press release, AstraZeneca announced that it is divesting global rights to its acid reflux medicine, Losec (omeprazole) and other medicines containing omeprazole to Germany’s pharma company, Cheplapharm. The divestment of the global commercial rights, excluding China, Japan, the United States and Mexico, of these mature medicines, will allow the company to focus on three main therapy areas - Oncology; Cardiovascular, Renal and Metabolism; and Respiratory. For the deal, AstraZeneca will get a payment of approximately $243 million from Cheplapharm on closure, plus sales-contingent milestones of up to $33 million in 2021 and 2022. Earlier, AstraZeneca had divested the commercial rights to Losec and other omeprazole medicines in the United States, Japan and Mexico.

Recently, at the European Society of Medical Oncology (ESMO) congress in Barcelona, Spain, AstraZeneca and partner Merck MRK presented detailed data from two late-stage label expansion studies on their PARP inhibitor, Lynparza. Data from the PAOLA-1 study showed that Lynparza added to bevacizumab as a first-line maintenance treatment reduced the risk of disease progression or death by 41% in women suffering from advanced ovarian cancer regardless of their biomarker status or surgical outcome. Meanwhile, in the phase III PROfound study, Lynparza doubled the time without radiographic disease progression in an advanced prostate cancer patient population.

At ESMO, AstraZeneca also presented new data from the phase III FLAURA study, which demonstrated superior overall survival benefit of Tagrisso to standard of care medicines in patients with EGFR mutated non-small cell lung cancer.

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