FDA Approves Tudorza Pressair (aclidinium bromide inhalation powder) Supplemental New Drug Application to include data for the Reduction of COPD Exacerbations and Hospitalizations.
M2 PHARMA-April 3, 2019-FDA Approves Tudorza Pressair (aclidinium bromide inhalation powder) Supplemental New Drug Application to include data for the Reduction of COPD Exacerbations and Hospitalizations
(C)2019 M2 COMMUNICATIONS
- The US Food and Drug Administration added new data to the Tudorza Pressair (aclidinium bromide inhalation powder) Prescribing Information that includes data from the ASCENT trial showing that Tudorza Pressair reduces exacerbations in chronic obstructive pulmonary disease and does not increase major adverse cardiovascular events in COPD patients with cardiovascular disease and/or significant cardiovascular risk factors, US-based Circassia Pharmaceuticals Inc said.
Tudorza Pressair is indicated for the maintenance treatment of patients with COPD.
COPD exacerbations, or "flare-ups," include a sudden worsening of symptoms such as shortness of breath, worsened cough, headaches.
Frequent exacerbations accelerate disease progression and death.
Exacerbations also lead to increased unscheduled physician and emergency room visits, which can add to the financial burden of COPD on individuals and the healthcare system.
ASCENT was a randomised, double-blind, placebo-controlled of up to 36-months study that evaluated the effect of Tudorza Pressair on MACE and exacerbations in 3,630 patients with moderate-to-very-severe COPD.
All patients had a history of cardiovascular or cerebrovascular disease and/or significant cardiovascular risk factors.
This phase IV trial found that, compared to placebo, Tudorza Pressair does not increase MACE and reduced exacerbations in the first year in COPD patients with high cardiovascular risk.
Tudorza Pressair is not a rescue medicine and should not be used for treating sudden breathing problems.
In this study, adverse reactions occurring at a rate of >=2% and more common than placebo were nausea, back pain, cough, hypertension, sinusitis, constipation, arthralgia, anemia, muscle spasms, cardiac failure congestive, cellulitis, and gastroesophageal reflux disease.
Please see complete Important Safety Information below and full prescribing information here.
COPD (chronic obstructive pulmonary disease) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which makes it hard to breathe and results in breathlessness.
According to the American Lung Association, COPD is the third leading cause of death in the United States.
More than 11m people have been diagnosed with COPD, but millions more may have the disease without knowing it.
COPD causes serious long-term disability and early death, and the number of people dying from COPD is growing.
According to the World Health Organization, the most common symptoms of COPD are breathlessness, chronic cough, and sputum (mucous) production.
Sufferers also frequently experience exacerbations, that is, serious episodes of increased breathlessness, cough and sputum production that last from several days to a few weeks.
These episodes can be seriously disabling and result in need for urgent medical care (including hospitalisation) and sometimes death.
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|Date:||Apr 3, 2019|
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