AstraZeneca plc (AZN - Free Report) announced top-line data from a late stage study, which showed that its Bevespi Aerosphere led to a statistically significant improvement in lung function in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
The phase III PINNACLE 4 study included more than 1700 patients across Asia, Europe and the United States. The study evaluated Bevespi Aerosphere administered twice daily via pMDI compared to its monotherapy components and placebo. The improvement in lung function was measured by trough forced expiratory volume in one second (FEV1).
AstraZeneca expects to file regulatory application in China and Japan supported by this latest data from the PINNACLE 4 study as well as past PINNACLE studies.
Bevespi Aerosphere is a fixed dose combination of glycopyrrolate -a long-acting muscarinic antagonist (LAMA) and formoterol fumarate- long-acting beta2-adrenergic agonist in a pressurized metered dose inhaler (pMDI), which is approved for the long-term maintenance treatment of airflow obstruction in COPD.
Bevespi was launched in the United States in January this year. The inhaler recorded sales of $4 million in the first half of 2017. Bevespi is under review in the EU with a launch expected next year.
Several LABA/LAMA combination treatments have been approved by the FDA in the past few years including GlaxoSmithKline’s (GSK - Free Report) Anoro Ellipta and Sunovion Pharmaceuticals/Novartis’ (NVS - Free Report) Utibron Neohaler.
Importantly, the respiratory therapeutic area saw the FDA approval of the first triple combination therapyfor COPD this month. Glaxo and partner Innoviva, Inc.’s (INVA - Free Report) once-daily single inhaler triple therapy, Trelegy Ellipta received FDA approval this month for the treatment of appropriate patients with COPD
A combination of an inhaled corticosteroid (“ICS”), a LAMA and a LABA, Trelegy Ellipta will provide patients with a convenient dosing option.
Respiratory is one of AstraZeneca’s main therapy areas with asthma and COPD treatments like Symbicort, Pulmicort Daliresp, Duaklir and others. The respiratory medicines, accounting for 23% of AstraZeneca’s total product revenue, generated sales of $2.28 billion in the first half of 2017, down 4% at constant exchange rates.
AstraZeneca also boasts a strong respiratory pipeline expecting to launch four new respiratory medicines between 2017 and 2020.
Promising late-stage/under review pipeline candidates include benralizumab (severe asthma and COPD), tralokinumab (severe asthma) and PT010 (COPD).
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