Tag Archives: approval

Alzheimer’s drug approved Monday by FDA raises questions for journalists


Photo: Knowing Roger via Flickr

Part two of two parts; the first ran Thursday, June 10.

There’s still a great deal we don’t yet understand about aducanumab (brand name Aduhelm) or its longer-term effects. If early-stage Alzheimer’s disease is diagnosed in time for someone to begin taking the drug, are the potential adverse effects cumulative? Could long-term toxicity build up over time? How long might the drug stave off development of the plaque, and how long might it slow down the process of cognitive decline, if at all, and how will clinicians assess its benefit in patients? Continue reading

FDA approves new Alzheimer’s drug, but controversy persists

Beta-amyloid plaques and tau in the brain.

National Institute on Aging/National Institutes of HealthBeta-amyloid plaques and tau in the brain.

Part one of two parts; the second runs tomorrow, Friday, June 11.

You might think that the first new drug to treat Alzheimer’s in 18 years — and the first to treat underlying disease and not just symptoms — would be heralded by patients, families, and medical professionals alike. After all, the FDA’s approval on Monday of  aducanumab (brand name Aduhelm) sounds like a tremendous breakthrough for the estimated 6 million Americans, and 50 million people globally, who suffer from the disease.

However, because of the supporting clinical data on its effectiveness, the drug has been controversial from the start. Drug maker Biogen actually halted its parallel Phase 3 studies, ENGAGE and EMERGE, because they failed to meet their primary endpoints. Those original endpoints were a change in the Clinical Dementia Rating-Sum of Boxes (CDR-SB), which is similar to a composite endpoint because it assesses improvement in multiple different domains. Continue reading

These FDA apps can be helpful for reporting and story ideas

If you are familiar with  Drugs@FDA, you know that the website allows you to quickly look up a drug by its name (brand), the active ingredient (generic), or application number. But if you frequently work on the go or need to look up something quickly while away from your computer, you now can download the FDA’s new app, Drugs@FDA Express (iOS/Apple and Android/Google), to see much of the same information.

Released in late March, the app is pretty basic, but often that’s the best kind of app. It loads quickly, isn’t overly cluttered and has simpler user-friendly interface. The opening page is straightforward. Continue reading

Does UnitedHealthcare’s prior-approval rule mean more ‘mother-may-I’ medicine is coming?

Photo: U.S. Pacific Fleet via Flickr

Photo: U.S. Pacific Fleet via Flickr

The nation’s largest health insurer will require physicians and hospitals to request prior approval before doing most hysterectomies, a move that may indicate a trend toward more pre-authorization for tests and procedures.

In a statement posted on its website, UnitedHealthcare cited evidence from the American Congress of Obstetricians and Gynecologists (ACOG) that shows better patient outcomes and fewer complications from vaginal hysterectomies than with laparoscopic or abdominal hysterectomies. The requirement for prior approval will be effective April 6. Patients undergoing outpatient vaginal hysterectomies do not need prior authorization, UHC said. Continue reading