- FDA reviewers support efficacy of Forest Labs' IV antimicrobial ceftaroline for treating pneumonia, complicated skin and skin structure infections
- FDA updates label for Pfizer's Tygacil to warn of increased mortality risk
- FDA approves Abbott's HBV molecular diagnostic for measuring viral load
- FDA approves new version of Allergan's Lumigan
- FDA approves Reckitt Benckiser's Suboxone sublingual film for treatment of opioid dependence
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
- Pediatric subspecialty telephone consultations may be cost-saving for Medicaid, research reveals
- Use of mental health services greater in health plans with parity in cost sharing, data find
- Public opinions appear split on health care affordability, satisfaction, survey finds
- In Brief: California Supreme Court
FDA panel rules against investigational NSAID after agency reviewers question BP-related benefits of drug
What's This?
A Food and Drug Administration panel voted 16-1 to recommend against approval of NicOx SA's naproxcinod, an investigational nonsteroidal anti-inflammatory drug (NSAID), for use in relieving the signs and symptoms of osteoarthritis. Panelists said there was not enough safety evidence from the company's trials of the NSAID to support its use. In documents released prior to the meeting, NicOx said naproxcinod combines the established efficacy of the NSAID naproxen with the...
A Food and Drug Administration panel voted 16-1 to recommend against approval of NicOx SA's naproxcinod, an investigational nonsteroidal anti-inflammatory drug (NSAID), for use in relieving the signs and symptoms of osteoarthritis.
Panelists said there was not enough safety evidence from the company's trials of the NSAID to support its use.
In documents released prior to the meeting, NicOx said naproxcinod combines the established efficacy of the NSAID naproxen with the "well-known effect of nitric oxide," which is intended to improve the safety profile by mitigating the NSAID-induced increase in blood pressure that can occur.
In separate documents, agency reviewers questioned the drug's effect on reducing blood pressure, particularly the variability of the effect seen through the dosing interval.
"Typically drugs with meaningful effects on cardiac outcomes have an effect on systolic and diastolic blood pressure that persists through the dosing interval," they wrote. "In this case the potential impact on cardiac outcomes is unclear."
FDA approves naproxen-esomeprazole combination drug 
What's This?
The Food and Drug Administration approved a combination drug containing naproxen and esomeprazole magnesium for relieving the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients who are at risk of developing them because of nonsteroidal anti-inflammatory drug (NSAID) use.The combination therapy combines delayed-release, enteric-coated naproxen...
Abatacept provides clinically meaningful efficacy, acceptable safety for RA patients, data reveal
What's This?
Abatacept appears to have an acceptable safety and tolerability profile and provides clinically meaningful efficacy over 6 months for patients with active rheumatoid arthritis who have had an inadequate response to anti-tumor necrosis factor (TNF) therapy, according to recent Phase IIIb data.In the international, open-label trial, 1,046 patients were treated with a fixed dose of abatacept of approximately 10 mg/kg on days 1, 15, and 29, and then every 4 weeks thereafter up to...
Lyon Schuss, fixed flexion radiographs provide similar reproducibility for joint space width but differences in joint space narrowing
What's This?
Lyon Schuss (LS) and fixed flexion (FF) radiographs provide similar reproducibility in the measurement of joint space width, but the LS view is much more sensitive in evaluating joint space narrowing in osteoarthritis (OA) knees, according to a recent head-to-head trial.The analysis included 161 women aged >=40 years and in good general health. Sixty-two patients had radiographic OA at baseline and 99 were age- and sex-matched controls without OA. Patients and controls were...
Oral JAK-3 inhibitor plus methotrexate efficacious, safe in RA
What's This?
By David MacDougallCP-690,550, an oral inhibitor of Janus kinase 3 (JAK-3), is safe and efficacious when used in combination with methotrexate in patients with rheumatoid arthritis (RA) who have had an inadequate response to methotrexate alone, according to findings from a double-blind, Phase IIb, dose-finding study.
JAK-3 is a tyrosine kinase essential for proper signal transduction downstream of selected cytokine...
ACR 2007 Scientific Meeting
November 6-11, 2007 Boston, MA- Etanercept provides sustained efficacy, improved patient-reported outcomes in AS
- Targeting the IL-6 cytokine pathway presents exciting opportunities in variety of disease states, experts report
- Rituximab efficacious in patients with inadequate response to TNF inhibitors in repeated courses
- Treatment expectations with TNF inhibitors
- Adalimumab improves peripheral arthritis, enthesitis, axial signs, symptoms of AS in patients with long-standing disease treated in real-life practice, researchers report
EULAR 2007 Annual Congress
June 13-16, 2007 Barcelona, Spain- Biologics represent useful treatment for PsA; other therapies, approaches require more study
- Repair of joint erosions in patients with RA occurs primarily in joints with no swelling, improvement in swelling, researchers report
- Adalimumab safe, effective in anti-TNF-pretreated patients with PsA, study data show
- Certolizumab pegol improves signs, symptoms of RA among patients with insufficient response to methotrexate, study data show
- Anti-TNF agents may slow, protect against RA-related joint destruction, disability, work loss
- Adalimumab improves peripheral arthritis, enthesitis, axial signs, symptoms of AS in patients with long-standing disease treated in real-life practice, researchers report
- Infliximab infusion may increase risk of ventricular arrhythmias in patients with RA, data suggest
- Adalimumab improves symptoms, patient-reported outcomes in patients with psoriasis, PsA, data show
- Tocilizumab improves function, QOL in patients with RA who respond inadequately to conventional DMARDs, researchers report
- Golimumab improves signs, symptoms, physical function among patients with AS, study data show
- Infliximab infusion may increase risk of ventricular arrhythmias in patients with RA, data suggest
- Canadian Rheumatology Association, Spondyloarthritis Research Consortium of Canada publish recommendations for treatment of SpA
- Denosumab, certolizumab show promise as potential treatments in RA
- Oral JAK-3 inhibitor plus methotrexate efficacious, safe in RA
- Increase in risk of heart failure slight among younger anti-TNF-treated patients with RA, Crohn's disease
