• Regulatory NewsRegulatory News

    FDA’s accelerated approval program: Is change on the way?

    The U.S. Food and Drug Administration (FDA) launched its accelerated approval program in 1992, offering a pathway to bring life-saving drugs and biologics to the market faster. After nearly 30 years, could substantial reforms be on the way?   At RAPS Convergence 2021, David Dorsey of Janssen R&D, said Congress could choose to make changes to the accelerated approval program through the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA). Congress has...
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    Pazdur mounts defense of accelerated approval during Cures 2.0 panel

    During a listening session convened by the Friends of Cancer Research (FOCR) with Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) on their nascent Cures 2.0 package, Richard Pazdur, director of the US Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) defended the agency’s accelerated approval program.   (RELATED: Cures 2.0: Discussion draft signals impact on FDA, creation of ARPA-H , Regulatory Focus 23 June 2021)   Asked by DeGette w...
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    FDA defends Aduhelm's accelerated approval, while others call for reform

    Three papers published as Viewpoints in JAMA Internal Medicine this week highlight the rationale provided by the US Food and Drug Administration (FDA) on the agency’s approval of aducanumab (Aduhelm; Biogen Inc), implications the approval could have for the Medicare program, and a contemplation on the future of FDA’s accelerated approval pathway.   Writing on behalf of FDA, Billy Dunn, MD, director of the Office of Neuroscience with FDA, and colleagues said the agenc...
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    FDA to study disclosure information for accelerated approval products in oncology

    The Office of Prescription Drug Promotion (OPDP) at the US Food and Drug Administration (FDA) wants to know how to better present disclosure information about products with accelerated approval to patients with cancer and their caregivers.   In two studies recently announced in the Federal Register , OPDP is seeking to confirm prior research on how patients interpret disclosure information for a product approved under FDA’s accelerated approval pathway on a direct-to-...
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    FDA calls in adcomm to review six more oncology accelerated approvals

    After drugmakers voluntarily withdrew four indications for their cancer drugs in recent months, the US Food and Drug Administration (FDA) on Thursday said it would convene an advisory committee to review six more oncology indications with accelerated approval after confirmatory trials failed to verify their clinical benefit.   Over the course of three days in April, FDA’s Oncology Drugs Advisory Committee (ODAC) will review six indications for Roche’s Tecentriq (atezol...
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    Industry-wide accelerated approval review yields four withdrawals

    Since late December, four drugmakers have voluntarily withdrawn indications for their cancer drugs amid an industry-wide review of accelerated approvals by the US Food and Drug Administration’s (FDA) Oncology Center of Excellence.   In each of their statements announcing the withdrawals, Bristol Myers Squibb, AstraZeneca, Merck and Roche said the withdrawal decisions were made in consultation with FDA as part of an industry-wide review of accelerated approvals with con...
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    Regulators discuss accelerated approvals, Project Orbis at DIA

    Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada gave their perspectives on different issues related to accelerated approval pathways in their respective jurisdictions at the DIA Global Annual Meeting.   All three regulators offer their own form of accelerated approval based on less comprehensive clinical data than a traditional marketing approval would require. In the US, that pathway is dubbed accelerated ap...
  • RoundupsRoundups

    FDA Approvals Roundup: Tauvid, Oriahnn, Sirturo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tauvid nabs approval as first drug to aid imaging of tau pathology FDA has approved Avid Radiopharmaceuticals’ radioactive diagnostic agent Tauvid (flortaucipir F18 injection) as the first drug to image tau pathology, a distinctive characteristic of Alzheimer’s disease in the brain.   The drug is indicated for intravenous administration bef...
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    Makena Withdrawal? A Look at the Timeline and Other Accelerated Approvals

    Earlier this week, an FDA advisory committee recommended that the agency withdraw Amag Pharmaceutical’s preterm birth drug Makena, a treatment that brought in more than $1 billion in sales before failing a confirmatory trial. The agency is now faced with the task of whether to take the committee’s vote and pull Makena from the market or allow it to remain until another confirmatory trial can be completed. Keeping Makena on the market would also present a rare situation,...
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    OND Director: New Approval Summaries Will Require FOIAs for Some Currently Available Data

    Closing out RAPS’ Regulatory Convergence on Tuesday afternoon, Peter Stein, director of the US Food and Drug Administration’s (FDA) Office of New Drugs (OND), confirmed to attendees that sponsors and other interested stakeholders looking to retrieve some of the data currently available in FDA-released drug approval packages would need to use the Freedom of Information Act (FOIA) to obtain some of that information under a new plan. While not getting into the specifics of...
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    Academics and Researchers Raise Concerns With FDA’s Plan for ‘Integrated Reviews’

    More than 50 academics and researchers from Harvard, Yale, Johns Hopkins and other universities around the world are calling on the US Food and Drug Administration (FDA) to not replace its original reviews of medical products with an “integrated review” because of the valuable information that would be lost. The researchers claimed that such a shift would deprive them of information and data on the clinical studies and trials submitted to FDA, information on the postmar...
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    Novartis’ Zolgensma Joins Growing List of Medicines to Lose Accelerated Assessment Status in EU

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently announced its decision to remove Novartis’ spinal muscular atrophy gene therapy onasemnogene abeparvovec from its accelerated assessment program. CHMP did not announce its reasoning behind the decision, which effectively means that the treatment, approved in the US as Zolgensma and launched at a price of more than $2 million, will be reviewed in the EU in 210 days rather...