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Unmet Medical Need Analysis of cardiomyopathy caused by transthyretin mediated amyloidosis (ATTR-CM): Approval of Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis)

On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM.

Unmet Medical Need (UMN) Parameters Current Unmet Medical Need in ATTR-CM Unmet Medical Need after Vyndaqel and Vyndamax
Treatment Adequacy Current treatment provides symptomatic relief. New treatment affects disease progression
Disease Severity Cardiac involvement has the worst prognosis and results in death in about 6 months after onset of congestive heart failure. New treatment affects severity of disease
Concerns of Payers & Providers Symptom reliefImproved cardiac outputShortened hospital stay Fewer emergency department visitsDecreased mortality New treatment provides symptom relief, significantly fewer cardiovascular-related hospitalizations & improvement in Physical Limitation, Quality of Life, and Social Limitation.
Net Unmet Medical Need Score 4.5/5 2.36/5
  High to very high UMN Low to moderate UMN

Vyndaqel and Vyndamax have disease modifying effect, affects disease severity and provides symptomatic relief as well as address patients, payers and providers concerns.

To get detailed analysis of unmet medical need and to understand our approach which we are using for unmet medical analysis of any disease please contact [email protected]

We help researchers in unmet medical need analysis of diseases which helps them in disease prioritization for any new drug/device/target/MOA development. We do unmet medical need analysis of any disease based on various parameters which is not limited to treatment adequacy, patient perspective, payer & providers perspective.

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