FDA approves Incruse Ellipta for COPD
FDA approved umeclidinium (Incruse Ellipta, GlaxoSmithKline) once-daily anticholinergic for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
FDA approved umeclidinium (Incruse Ellipta, GlaxoSmithKline) once-daily anticholinergic for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Umeclidinium is GSK’s first once-daily anticholinergic, a type of bronchodilator also known as a long-acting muscarinic antagonist (LAMA). It is approved with the Ellipta inhaler. Its approved strength is 62.5 µg.
The drug’s anticipated launch in the United States will be during the fourth quarter of 2014.
The phase 3 randomized, placebo-controlled clinical studies for umeclidinium included seven clinical studies, which involved more than 2,500 COPD patients treated with umeclidinium or placebo. Nasopharyngitis (8%), upper respiratory tract infection (5%), cough (3%), and arthralgia (2%) were the most common adverse events.
GSK’s other approved drugs for COPD are Breo Ellipta, a fluticasone furoate and vilanterol inhalation powder and Anoro Ellipta, umeclidinium and vilanterol inhalation powder.
The National Heart, Lung and Blood Institute (NHLBI) estimates that nearly 27 million people in the United States alone have COPD. Most individuals first exhibit symptoms associated with COPD at approximately mid-life or 40 years old.
Remote Care Advancement for Heart Failure, COPD and Diabetes Patients
February 24th 2021In this week's episode of Tuning In to the C-Suite podcast, MHE's Briana Contreras spoke with Dr. Rob Kowal, chief medical officer of the Cardiac Rhythm and Heart Failure division at Medtronic. The two discussed how remote monitoring and IoT is changing healthcare and how remote technology is also gaining a wide-spread adoption to monitor patients at home who have chronic conditions like heart failure, chronic obstructive pulmonary disease and diabetes.
Listen
FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
Read More
