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    • Pfizer gets USFDA...

    Pfizer gets USFDA approval for Vyndaqel, Vyndamax to treat amyloidosis cardiomyopathy

    Farhat NasimWritten by Farhat Nasim Published On 2019-05-11T09:15:58+05:30  |  Updated On 16 Aug 2021 11:25 AM IST

    New Delhi: Pfizer Inc's subsidiary FoldRx, has recently won U.S. Food and Drug Administration (USFDA) approved for 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.


    Vyndaqel and Vyndamax have the same active moiety, tafamidis, but they are not substitutable on a milligram to milligram basis and their recommended doses differ.


    "Transthyretin-mediated amyloidosis is a rare, debilitating and often fatal disease," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drugs in the FDA's Center for Drug Evaluation and Research.


    "The treatments we're approving today are an important advancement in the treatment of the cardiomyopathy caused by transthyretin-mediated amyloidosis."


    Read Also: USFDA approves perfusion device Xvivo Perfusion System for lung transplants


    ATTR is caused by the buildup of abnormal deposits of specific proteins known as amyloid in the body's organs and tissues, interfering with their normal functioning. These protein deposits most frequently occur in the heart and the peripheral nervous system. Heart involvement can result in shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms and death.


    Involvement of the peripheral nervous system can result in a loss of sensation, pain, or immobility in the arms, legs, hands and feet. Amyloid deposits can also affect the kidneys, eyes, gastrointestinal tract and central nervous system.


    The efficacy of Vyndaqel and Vyndamax in treating ATTR-CM was shown in a clinical trial of 441 patients randomized to receive Vyndaqel or a placebo. After an average of 30 months, the survival rate was higher in the Vyndaqel group than in the placebo group. Vyndaqel was also shown to reduce the number of hospitalizations for cardiovascular problems.


    The number of patients in clinical studies was small, but no drug-associated side effects have been identified. Tafamidis may cause fetal harm when administered to a pregnant woman. Women taking Vyndaqel or Vyndamax should discuss pregnancy planning and prevention with their health care professional.


    The FDA granted Vyndaqel Fast Track, Priority Review and Breakthrough Therapy designation. Vyndaqel and Vyndamax each received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.


    Read Also: FDA approves generic of Advair Diskus for asthma

    abnormal heart rhythmsamyloidosisATTR CMbreathcardiomyopathydeathfatigueFDA approvesFoldRxheart diseaseheart failureloss of consciousnessMedical DevicesNorman StockbridgePfizerrare diseaseRenal Drugstafamidis capsulestafamidis megluminetransthyretintransthyretin mediated amyloidosistreatmentsVyndamaxVYNDAQEL

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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