FDA approves a fixed-dose combination inhaler for COPD maintenance
The FDA approved Duaklir Pressair, a fixed-dose combination of aclidinium bromide and formoterol fumarate, for the maintenance treatment of chronic obstructive pulmonary disease (COPD). It is administered twice daily by oral inhalation with AstraZeneca's breath-actuated Pressair inhaler.
Duaklir Pressair is the only twice-daily, long-acting muscarinic antagonist (aclidinium bromide) and long-acting beta2-adrenergic agonist (formoterol fumarate) approved in the US with COPD exacerbation data in its prescribing information.
The safety and efficacy of Duaklir Pressair was evaluated in a clinical development program that included three dose-ranging trials of patients with COPD. The results supported the selection of 400 mcg of aclidinium bromide twice daily and 12 mcg of formoterol fumarate twice daily in the confirmatory COPD trials.
New topical treatment for plaque psoriasis
The FDA approved halobetasol propionate and tazarotene (Duobrii) lotion for the treatment of plaque psoriasis in adults. The lotion is the first and only topical lotion combining halobetasol propionate and tazarotene in one formulation.
A phase II clinical trial showed that the lotion was consistently more effective than its individual agents and the vehicle in achieving treatment success and reducing psoriasis signs of erythema, plaque elevation, and scaling at the target lesion.
Osteoporosis drug approved for postmenopausal women
Amgen's osteoporosis treatment romosozumab-aqqg (Evenity) was approved for use in postmenopausal women at high risk for fracture. According to Amgen, it is the first and only osteoporosis medication that both increases bone formation and to a lesser extent reduces bone resorption to rapidly reduce the risk of fracture. Romosozumab-aqqg, a humanized monoclonal antibody sclerostin inhibitor, is administered as two separate subcutaneous injections, one immediately following the other, given once a month by a healthcare provider. The anabolic effect of romosozumab-aqqg wanes after 12 monthly doses of therapy. Therefore, the duration of the drug should be limited to 12 monthly doses. If osteoporosis therapy is still warranted, therapy with an antiresorptive agent should be considered. The most common adverse reactions reported with romosozumab-aqqg were arthralgia and headache.
Romosozumab-aqqg was approved on the basis of clinical trial results that patients treated with the drug showed a significant decrease in new vertebral fractures at 12 months compared with placebo. Romosozumab-aqqg has a boxed warning on the product labeling for the increased risk of myocardial infarction (MI), stroke, and cardiovascular death. Romosozumab-aqqg should not be used in patients who have had an MI or stroke in the past year.
New prescription weight management therapy approved
The FDA approved Plenity, an oral nonstimulant, nonsystemic hydrogel therapy to aid in weight loss for adults struggling with overweight and obesity.
Plenity is not a drug and is considered a medical device because it achieves its primary intended purpose through mechanical modes of action consistent with mechanobiology constructs. Plenity is indicated to aid in weight management in overweight and obese adults with a body mass index of 25 to 40 kg/m2, when used in conjunction with diet and exercise.
Plenity is taken with water 20 to 30 minutes before lunch and dinner. Each dose includes 3 capsules of Plenity provided in a single blister pack. The capsules release thousands of superabsorbent hydrogel particles that rapidly absorb water in the stomach and mix with ingested foods, creating a larger volume with higher elasticity and viscosity in the stomach and small intestine, contributing to satiety and fullness without any caloric value. Plenity particles are not absorbed and are eliminated through the feces.
In clinical trials, Plenity was effective and had a high safety and tolerability profile. The most commonly reported adverse reactions included gastrointestinal disorders.