FDA: Incorrect dosage of liver medication could cause injury, death | HCV response rates similar for specialty pharmacies, clinical trials | FDA grants orphan status to Amicus' Pompe disease therapy
September 22, 2017
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Leading News
FDA: Incorrect dosage of liver medication could cause injury, death
The FDA warned that incorrect dosages of Ocaliva, or obeticholic acid, could lead to serious liver injury or death in some patients. The FDA said, "Patients with moderate to severe liver impairment (Child-Pugh B and C) should be started on the approved dosing schedule of 5 mg once weekly, rather than the 5 mg daily dosing used for other PBC patients, and if needed, can be increased up to a maximum approved dose of 10 mg twice weekly."
Rare Disease Report (9/21) 
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Specialty Pharmacy Update
HCV response rates similar for specialty pharmacies, clinical trials
A retrospective chart review presented at the National Association of Specialty Pharmacy meeting found that hepatitis C patients treated by a specialty pharmacy attained sustained virologic response rates of 93.9%, comparable to those achieved in clinical trials. Patients were part of an OptiMed management program that included adherence augmentation, pharmacist-patient counseling, drug interaction interventions, proactive refill management and evidence-based evaluations and recommendations for treatment.
Specialty Pharmacy Times (9/21) 
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Legislation & Regulation
FDA grants orphan status to Amicus' Pompe disease therapy
Amicus Therapeutics' ATB200/AT2221, indicated for the treatment of Pompe disease, received orphan drug designation from the FDA.
Seeking Alpha (free registration) (9/21) 
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Medicaid directors speak out against Graham-Cassidy ACA repeal legislation
The National Association of Medicaid Directors, the latest organization to oppose the GOP's newest attempt to repeal portions of the Affordable Care Act, said the Graham-Cassidy bill would put a massive financial burden on states on a timeline that is too short for setting up programs. The group also criticized the push to vote quickly, before a Congressional Budget Office score is available, arguing that the score "should be the bare minimum required for beginning consideration."
The Examiner (Washington, D.C.) (9/21),  The Hill (9/21) 
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Clinical & Research News
Study evaluates safety, efficacy of direct-acting antivirals among adolescents
Investigators from the University of California at San Francisco found that adolescents diagnosed with hepatitis C virus genotype 2 or 3 who underwent a 12-week treatment regimen with an all-oral combination of Sovaldi, or sofosbuvir, and ribavirin had a 98% cure rate, according to a study of 52 participants between the ages of 12 and 17 in the journal Hepatology. The study was conducted across 30 sites in the US, Australia, Germany, Italy, New Zealand, Russia and the UK.
MD Magazine online (9/20) 
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Baricitinib better than methotrexate in patient-reported outcomes
An analysis reported in the journal Arthritis Research & Therapy found baricitinib, a selective JAK1-2 inhibitor, was linked to greater improvements in self-reported outcomes among rheumatoid arthritis patients compared with methotrexate. Eli Lilly and Co. plans to resubmit its application to the FDA by the end of January.
MedPage Today (free registration) (9/21) 
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Trends & Technology
Specialty drugs to drive increase in employee health benefits costs
A new report from human resources consulting company Mercer predicts that average per-employee health benefits costs will increase by 4.3% next year and costs of specialty drugs will increase more than 7%. "With so many new specialty drugs in the pipeline and few well-known brand-name drugs going off-patent in the near future, the spiraling drug cost problem will certainly get worse before it gets better," said Mercer Senior Partner Tracy Watts.
Drug Topics (9/20) 
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Study finds widespread failure to conduct post-approval safety studies
Drugmakers never began 20% of the post-approval safety studies required in 2009 and 2010, and 9% of those studies were delayed, researchers reported in The New England Journal of Medicine. Drugmakers and the FDA said the study's conclusions are inaccurate.
Reuters (9/21) 
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It is a thing of no great difficulty to raise objections against another man's oration -- nay, it is a very easy matter -- but to produce a better in its place is a work extremely troublesome.
Plutarch,
biographer and essayist
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