Metabolic Disorders

Does Obesity Impact Virological Response in HCV Patients on DAA Therapy?

By November 14, 2018

The review analyzed 168 patients treated with an oral DAA at a single center from 2015 to 2017.

HHS: Updated Physical Activity Guidelines for Americans Released

By November 12, 2018

This guidance, updated for the first time since 2008, provides evidence-based recommendations for children (ages 3-17) and adults.

Updated Infant Administration Procedure Approved for Nityr

By November 12, 2018

The labeling now states that a caregiver may disintegrate the Nityr tablet in an oral syringe up to 24 hours before administration.

New Single-Vial Formulation of Egrifta Approved to Treat Excess HIV-Related VAT

By November 06, 2018

The new "F4" formulation is 4 times more concentrated than the version currently available on the market.

Antibiotics, Acid Suppressants in Infancy May Up Obesity Risk

November 01, 2018

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).

Gastric bypass most effective for weight loss among common bariatric procedures

October 31, 2018

Roux-en-Y gastric bypass was found to be the most effective bariatric procedure reviewed in this study in terms of patient weight loss.

Development Program for Glut1 Deficiency Syndrome Drug to Be Discontinued

By October 26, 2018

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).

Saxenda Labeling Updated With Cardiovascular Safety Data

By October 23, 2018

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.

Obesity Negatively Affects Treatment Response to JAK Inhibitors in RA

October 22, 2018

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.

Triple Combo Regimens May Address Cause of Cystic Fibrosis

October 19, 2018

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.

Sharp Drop in US Life Expectancy Rankings by 2040

October 19, 2018

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.

Novel Inhaled Treatment for Cystic Fibrosis Granted Orphan Drug Designation

By October 11, 2018

SNSP113 is intended to improve lung function in CF patients by targeting key drivers of pulmonary decline such as infection, airway congestion and inflammation.

Revcovi Approved for Adenosine Deaminase Severe Combined Immune Deficiency

By October 09, 2018

The FDA approval was supported by data from 2 multicenter, open-label clinical trials (Study 1 [N=6] and Study 2 [N=4])

Tegsedi Approved for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis

By October 09, 2018

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.

Lorcaserin Reduces Risk of Incident Diabetes in Patients With Prediabetes

By October 05, 2018

In this new analysis, researchers looked at the long-term effects of the drug on diabetes prevention and remission in these patients.

Treatment for Transthyretin Amyloidosis Granted Orphan Drug Designation

By October 04, 2018

The Company expects to start Phase 3 studies for ATTR cardiomyopathy and polyneuropathy in the first half of 2019.

USPSTF Recommends Intensive Behavioral Change for Obesity

September 20, 2018

Task Force finds adequate evidence that multi-part interventions can improve weight status

FDA Fast-Tracks Miransertib for PIK3CA-Related Overgrowth Spectrum

By September 14, 2018

Miransertib is an orally available, selective, pan-AKT (protein kinase B) inhibitor that potently inhibits AKT1, 2 and 3 isoforms.

Updated Contraindications, Dosing for Gaucher Disease Treatment Cerdelga

By September 04, 2018

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.

FDA Issues CRL Rejecting Waylivra Approval for Familial Chylomicronemia Syndrome

By August 28, 2018

"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.

Lorcaserin Facilitates Weight Loss Without Increasing Risk of Major CV Events

By August 27, 2018

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.

Kalydeco Approved to Treat Cystic Fibrosis in Children 12 to <24 Months

By August 17, 2018

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).

Low-Energy Diet Induces Different Effects in Men, Women

August 15, 2018

Men had larger reductions in metabolic syndrome Z-score, C-peptide, fat mass, heart rate

Galafold Approved for the Treatment of Adults With Fabry Disease

By August 13, 2018

The indication was approved under an accelerated approval pathway based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate.

First-in-Class Therapy Approved for Polyneuropathy Caused by hATTR

By August 10, 2018

The mechanism of siRNAs consists of silencing a portion of RNA involved in causing the disease.

FDA Grants Orphan Drug Status to Angelman Syndrome Treatment

By August 10, 2018

Delay or lack of speech, seizures, and walking/balance disorders are some of the symptoms associated with AS.

AHA: A Diverse Diet May Not Promote a Healthy Weight

August 10, 2018

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.

Orkambi Approved to Treat Younger Cystic Fibrosis Patients

By August 08, 2018

The approval was based on data from a 24-week, open-label, Phase 3 study in patients aged 2 to 5 years.

PCOS and Overweight/Obesity: Drug Therapies for Weight Reduction Compared

By August 06, 2018

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.

Obesity Treatments

August 03, 2018

A comparative list of medications by pharmacological class for the treatment of obesity.