FDA 2019 approvals for COPD treatment included a cryotherapy spray and other novel & breakthrough therapies. Updates at-a-glance, here.
"This emphasizes the need for clinicians to focus on both the short-term and long-term impact of COPD on their patients."
-GOLD 2020 on current COPD treatment objectives
First Advair Diskus generic gets FDA nod. The FDA approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for twice-daily treatment of asthma in patients aged ≥4 years; maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and emphysema; and reducing COPD exacerbations. Advair Diskus is not indicated for relief of acute bronchospasm. The product is available in 100 µg/50 µg, 250 µg/50 µg, and 500 µg /50 µg strengths for asthma and 250 µg /50 µg for COPD.
FDA approves LAMA/LABA combo. Duaklir, a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide (400 µg) and long-acting beta-agonist (LABA) formoterol fumarate (12 µg), received FDA approval for maintenance treatment for patients with COPD. Duaklir is administered twice-daily via the breath-actuated inhaler Pressair. The approval was supported by 3 phase 3 trials.
Cryotherapy spray for COPD with bronchitis. The FDA designated the RejuvenAir® System as a Breakthrough Device and granted unconditional investigational device exemption approval to initiate a clinical study to treat patients who have moderate to severe COPD with chronic bronchitis. The RejuvenAir System uses a metered cryospray of liquid nitrogen at -196â¦C in targeted areas within the lungs.
Nebulized bronchodilator approved. The FDA approved revefenacin (Yupelri), the first once daily nebulized bronchodilator for patients with COPD. The approval was based on replicate Phase III efficacy and safety studies in which revefenacin, a novel, lung-selective LAMA, demonstrated clinically significant improvements in 24-hour trough FEV1 and overall treatment effect FEV1 in patients with moderate to very severe COPD. Administered once daily for 12 weeks, revefenacin was generally well tolerated with no major safety concerns.
Aspirin may ease COPD morbidity as well as mortality. Daily aspirin use, already associated with a reduction in all-cause mortality, reduced morbidity in a study of SPIROMICS participants. Aspirin users had a lower incidence rate of total acute exacerbations of COPD (AECOPD), with similar effect for moderate but not severe AECOPD. Aspirin use also was associated with less dyspnea and better quality of life. The authors called for randomized clinical trials of aspirin use in COPD. The study appeared in Chest.
Breakthrough cystic fibrosis therapy. The FDA approved Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy available for patients with F508del, the most common cystic fibrosis mutation. Trikafta is approved for patients aged ≥12 years who have at least 1 F508del mutation in the CFTR gene, which represents about 90% of the cystic fibrosis population. Currently, many patients have mutations that are ineligible for treatment.
Macrolides reduce frequency of acute exacerbations. Long-term low dose use of macrolides could significantly reduce the frequency of AECOPD. An exploratory meta-analysis showed a 23% relative risk reduction in COPD exacerbations and a prolonged median time to first exacerbation among patients taking macrolides compared with placebo. The treatment was well tolerated but was not suitable for older patients. The study was published in the International Journal of Chronic Obstructive Pulmonary Disease.
New Drug Application rejected. The FDA issued a complete response letter to AstraZeneca regarding the company’s New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate), an inhaled triple-combination therapy and potential new medicine for patients with COPD. The company stated that next steps will include submitting for review recent results from the second positive Phase III trial, ETHOS, which had not been completed when the NDA was submitted.
Novel respiratory drug approvals. In addition to Trikafta, the FDA’s Center for Drug Evaluation and Research approved several novel drugs for respiratory disorders in 2019: Sunosi (solriamfetol) for excessive sleepiness in adults with obstructive sleep apnea, Pretomanid Tablets in combination with bedaquiline and linezolid for a specific type of highly treatment-resistant tuberculosis of the lungs, and Xenleta (lefamulin) for adults with community-acquired bacterial pneumonia.
Drugs in development. Inhaled bronchodilators and corticosteroids remain a mainstay of COPD treatment, but new and more effective pharmacological treatments are needed, according to the authors of a review in Clinical Pharmacology & Therapeutics. Close to 25 novel drug targets for COPD are in development. Most current medications treat symptoms and not underlying inflammation or disease progression. Novel investigational products that target immune mediators show particular promise.
For primary care and other clinicians who treat COPD, 2019 was a year of innovation.FDA approved the first once-daily nebulized bronchodilator; a Breakthrough Device that delivers cryotherapy; and, the first generic of Advair Diskus. In other developments, aspirin was found to reduce COPD mortality and macrolides to reduce frequency of acute exacerbations.Scroll through the slides below for short summaries of these and other news important to optimal management of COPD.