Date: 2012-07-24
Type of information:
Product name: Tudorza™ Pressair™
Compound: aclidinium bromide inhalation powder
Therapeutic area:
Action mechanism: Tudorza™ is a twice-daily inhaled long-acting anticholinergic, also referred to as a long-acting muscarinic antagonist (LAMA). It produces bronchodilation by inhibiting acetylcholine’s effect on muscarinic receptors in the airway smooth muscle. Aclidinium is rapidly hydrolyzed in human plasma into two major inactive metabolites.
Tudorza™ is administered using a multiple-dose dry powder inhaler, Pressair, which delivers 60 doses of aclidinium bromide powder for inhalation. The Pressair inhaler has a colored control window and audible “click” which confirm successful inhalation of the dose and a dose indicator to let patients know the approximate number of doses remaining in the inhaler.
Company: Almirall (Spain) Forest Laboratories (USA)
Disease: long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Latest news: * On July 24, 2012, Almirall and Forest Laboratories have announced that the FDA has approved Tudorza™ Pressair™ (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Forest expects Tudorza™ Pressair™ to be available to wholesalers in the fourth calendar quarter of 2012.
The Tudorza™ Pressair™ clinical development program included a dose-ranging trial and 3 confirmatory pivotal trials. The two 12-week and one 24-week pivotal placebo-controlled trials evaluated the efficacy and safety of Tudorza™ 400 mcg twice daily in 1,277 patients. Patients enrolled in these trials had a clinical diagnosis of COPD, were 40 years of age or older, had a smoking history of at least 10 pack-years, a post-bronchodilator forced expiratory volume in one second (FEV1) of at least 30% and less than 80% of predicted normal value, and a ratio of FEV1 over forced vital capacity (FEV1/FVC) of less than 0.7.
In all 3 pivotal trials, Tudorza™ Pressair™ demonstrated statistically significant improvements in bronchodilation, as measured by change from baseline in morning pre-dose trough FEV1 at 12 weeks (the primary endpoint) compared to placebo. The mean 12-week pre-dose FEV1 improvements vs placebo were 0.12 L, 0.07 L, and 0.11 L in the 3 trials, with a 24-week improvement of 0.13 L in the 6-month trial. Mean peak improvements in lung function assessed after the first dose of Tudorza were similar to those observed at week 12 in each study. Tudorza™ had a low incidence of side effects in these trials.
The most common adverse reactions that occurred in the Tudorza™ Pressair™ group with a frequency of greater than or equal to 3% and exceeding placebo were headache (6.6% vs 5.0%), nasopharyngitis (5.5% vs 3.9%), and cough (3.0% vs 2.2%). Three long-term safety studies, evaluating 891 patients treated with Tudorza™ Pressair™ 400 mcg twice daily for 40 to 52 weeks reported similar adverse events, with no new safety findings compared to the placebo-controlled trials.
Additionally, serial spirometric evaluations of FEV1 were performed over 12 hours in a subset of patients in the three trials. Improvement of lung function with Tudorza™ Pressair™ versus placebo was achieved for the first 12 hours on day 1 and was consistent over the 3- or 6-month treatment period evaluated.
In two of the three trials, patients treated with Tudorza Pressair also used less daily rescue albuterol compared to placebo treated patients.
European approval of aclidnium expected in Q3 2012.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2012-07-24
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
