This guidance, updated for the first time since 2008, provides evidence-based recommendations for children (ages 3-17) and adults.
The labeling now states that a caregiver may disintegrate the Nityr tablet in an oral syringe up to 24 hours before administration.
The new "F4" formulation is 4 times more concentrated than the version currently available on the market.
The researchers found that 72.4, 11.8, and 3.3% of children were prescribed an antibiotic, an H2RA, and a PPI, respectively. There was an association between antibiotic prescriptions and obesity (hazard ratio, 1.26).
Roux-en-Y gastric bypass was found to be the most effective bariatric procedure reviewed in this study in terms of patient weight loss.
The decision was made after results from a Phase 3 trial (N=44) comparing UX007 to placebo did not show a statistically significant reduction in paroxysmal movement events in favor of the treatment (primary endpoint).
The randomized, double-blind, placebo-controlled, parallel-group study (N=9340) evaluated the time from randomization to first occurrence of major adverse CV events (MACE) (non-fatal heart attack, non-fatal stroke, CV death) in patients treated with liraglutide 1.8mg once daily or placebo.
Patients treated with JAK inhibitors for rheumatoid arthritis may be less likely to have low disease activity if they are obese compared with those who are overweight.
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.
Life expectancy in the US has declined in each of the past 2 years, according to the National Center for Health Statistics. That's the first multi-year decrease since 1962 and 1963.
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 FDA approval was supported by data from 2 multicenter, open-label clinical trials (Study 1 [N=6] and Study 2 [N=4])
The approval was based on data from the Phase 3 NEURO-TTR study (N=173) which randomized patients with polyneuropathy caused by hATTR amyloidosis to Tegsedi or placebo.
In this new analysis, researchers looked at the long-term effects of the drug on diabetes prevention and remission in these patients.
The Company expects to start Phase 3 studies for ATTR cardiomyopathy and polyneuropathy in the first half of 2019.
Miransertib is an orally available, selective, pan-AKT (protein kinase B) inhibitor that potently inhibits AKT1, 2 and 3 isoforms.
Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers, intermediate metabolizers, or poor metabolizers as detected by an FDA-cleared test.
"We are extremely disappointed with the FDA's decision. We continue to feel strongly that Waylivra demonstrates a favorable benefit/risk profile in people with FCS," said Akcea CEO, Paula Soteropoulos.
In the CAMELLIA-TIMI 61 study, 12,000 overweight or obese patients with atherosclerotic cardiovascular disease or multiple cardiovascular risk factors were randomized to receive either lorcaserin 10mg twice daily or placebo.
The approval was supported by data from ARRIVAL (N=25), an ongoing Phase 3 open-label safety study in children with CF aged 12 to <24 months with 1 of 10 CFTR gene mutations (G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, G1349D or R117H).
The indication was approved under an accelerated approval pathway based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate.
The authors report that current data do not support greater dietary diversity as an effective strategy to promote healthy eating patterns and healthy body weight.
Researchers identified 23 randomized-controlled trials that included patients with PCOS and overweight/obesity (N=941) and compared the effectiveness of various pharmacological interventions (i.e., metformin, inositol, liraglutide, orlistat) on weight reduction.