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    • Roche anticipates...

    Roche anticipates USFDA nod for SMA drug Risdiplam by early 2020

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-11-26T09:28:41+05:30  |  Updated On 17 Aug 2021 10:34 AM IST

    Roche, whose drug Risdiplam is seen as a rival for Biogen's Spinraza and Novartis's Zolgensma gene therapy, said the FDA is due to decide by May 24.


    ZURICH: Roche expects its Risdiplam medicine for spinal muscular atrophy (SMA) to get U.S. approval by May, the Swiss drugmaker said on Monday, as it takes on Novartis and Biogen in the lucrative rare disease area.


    The U.S. Food and Drug Administration (USFDA) granted priority review for Risdiplam, oral medicine for those with the potentially deadly muscle-wasting disorder. Roche, whose drug is seen as a rival for Biogen's Spinraza and Novartis's Zolgensma gene therapy, said the FDA is due to decide by May 24. Roche is seeking broad approval for people into adulthood with different forms of SMA, including the deadly Type 1 disease that kills many infants in their first months of life as well as Type 3 disease that may set in later but still leaves its victims with profound physical disabilities.


    SMA is becoming a hard-fought battleground for drugmakers, as an urgent need for treatments has helped lead to some of the highest prices in the pharmaceuticals industry.


    Spinraza, administered via a spinal infusion, costs $750,000 for the first year and half that for every year thereafter, while Novartis's Zolgensma is the industry's most-expensive one-time treatment at $2.1 million per patient.


    Read Also: Tecentriq-Avastin cocktail helps liver cancer patients live longer: Roche


    Roche trials "were designed to represent the real-world spectrum of people living with SMA and include many people previously underrepresented in clinical trials," Roche Chief Medical Officer Levi Garraway said in a statement.


    Spinraza booked $1.7 billion in revenue in 2018, but this year has begun to face competition from Zolgensma after the gene therapy's approval in May. Zolgensma sales were $175 million through September.


    Read Also: FIRST: Roche wins DCGI nod for Atezolizumab to treat small-cell lung cancer

    Biogenclinical trialsgene therapyNovartisrisdiplamRochespinal infusionspinal muscular atrophySpinrazaUSFDAZolgensma
    Source : Reuters

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    Medical Dialogues Bureau
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      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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