Miscellaneous Respiratory Disorders
The approval was based on data from the IMpower 150 trial, an open-label study involving 1202 patients with stage IV metastatic NSq NSCLC who had not received prior chemotherapy for metastatic disease, but could have received prior EGFR or ALK kinase inhibitor if appropriate, regardless of PD-L1 or T-effector gene status and ECOG performance status 0 or 1.
A team of authors performed a systematic review of studies examining anti-inflammatory treatments for pediatric OSA through June 28, 2018 using PubMed/MEDLINE and 4 other databases.
The researchers found that participants in the highest quartile of vitamin D levels had significantly higher cardiorespiratory fitness than participants in the lowest quartile.
In patients with idiopathic pulmonary fibrosis (IPF) and a low diffusion capacity for carbon dioxide (DLCO), the addition of sildenafil to a treatment regimen of nintedanib did not improve quality of life scores after 12 weeks compared to treatment with nintedanib and a placebo.
"One of the most commonly prescribed antihypertensives, HCTZ is associated with rare cases of pulmonary edema, which typically develop within minutes to hours of the initial dose of the medication," the study authors stated.
The researchers observed significant improvement in the processing and trafficking of the Phe508del CFTR protein with VX-659-tezacaftor-ivacaftor, as well as improved chloride transport in vitro.
In both studies, at 24 weeks, patients treated with dupilumab plus corticosteroid nasal spray experienced a 51% and 57% improvement in nasal congestion/obstruction severity vs 15% and 19% improvement with nasal spray alone.
After high flow nasal cannula oxygen therapy, 15% of patients had to be intubated and mechanically ventilated, but the majority stepped down to regular oxygen therapy.
When treated with pirfenidone, patients with idiopathic pulmonary fibrosis experienced significant improvements in 6-minute walking distance and University of California San Diego Shortness of Breath Questionnaire scores.
SNSP113 is intended to improve lung function in CF patients by targeting key drivers of pulmonary decline such as infection, airway congestion and inflammation.
The approval was based on Phase 3 data from 2 studies in ABSSSI, where treatment with Nuzyra was compared with linezolid, and 1 study in CABP comparing Nuzyra with moxifloxacin. Across all 3 trials, Nuzyra was found to be effective and generally safe and well-tolerated.
"Because telemedicine encounters are short and physicians are often reimbursed by encounter volume, antibiotic stewardship efforts that lengthen visits even slightly may be challenging to implement," the authors write.
The researchers found that there was no significant difference between the nintedanib-plus-sildenafil group and the nintedanib group in terms of the adjusted mean change from baseline in the SGRQ total score at week 12 (−1.28 and −0.77 points, respectively; P=.72).
There was an association between 25(OH)D deficiency and increased prevalence of interstitial lung abnormalities 10 years later.
Multivariable predictors included oxygen saturation <90%, nasal flaring and/or grunting, apnea, retractions, age ≤2 months, dehydration, and poor feeding (odds ratios, 8.9, 3.8, 3.0, 3.0, 2.1, 2.1, and 1.9, respectively).
The primary objective was to characterize the long-term safety and tolerability of Ofev in patients with IPF; efficacy endpoints included annual rate of decline in forced vital capacity (FVC) calculated over 192 weeks.
The FDA's designation was based on data from a Phase 2 placebo-controlled trial that demonstrated pamrevlumab could potentially address an unmet medical need for this condition.
The full findings from the study will be presented at a future scientific conference; Merck plans to include the data in a supplemental New Drug Application for Zerbaxa which will be submitted to the Food and Drug Administration.
Liquid nitrogen isn't toxic, but its extremely low temperature can cause severe damage to skin and internal organs if mishandled or consumed, the FDA said in a news release.
Those at highest risk from the recalled products include infants, children, pregnant women, and people with weakened immune systems, the FDA said.
It predicts between 470 and 1,400 premature deaths a year by 2030 because of increased levels of microscopic airborne particulates, which are linked with heart and lung disease and chronic problems like asthma and bronchitis, The Times reported.
The median OS was not reached at the time of the data cut-off in the pembrolizumab plus chemotherapy arm and was 11.3 months for those in the chemotherapy arm.
Data showed that 12% responded to treatment based on assessment by a Blinded Independent Central Review, regardless of PD-L1 expression; 11% had a partial response, and 1 patient had a complete response (0.9%).
Bronchiolitis obliterans is the leading cause of morbidity and mortality in the pulmonary transplant population with ≥50% of patients who receive a lung transplant developing the condition within 5 years.
The Committee's recommendation was based on data from the omadacycline global development program that included nearly 2000 adults in three Phase 3 studies.
The recommendation was supported by materials developed from the ALIS New Drug Application (NDA), which included data from the CONVERT study.