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    Expedited FDA approval plays dominant role in drug approvals


    FDA approvals for generic drugs outpaced new drugs in 2016, according to speakers at the AMCP Managed Care & Specialty Pharmacy Annual Meeting, in Denver, during the March 28 session, “Traditional Brand and Generic Drugs in Development.”

    Last year saw “the highest number of generic drug approvals in the history of the FDA’s generic drug program,” reported Doris J. Kao, PharmD, BCPS, FCSHP, supervisor of Kaiser Permanente’s Drug Information Services in Oakland, California, and Anne Tran-Pugh, PharmD, coordinator of Kaiser Permanente’s National Medicare Formulary in Downey, California.

    The FDA’s Office of Generic Drugs approved 630 abbreviated new drug applications and tentatively approved another 183, Kao reported.

    Among first-time generic launches in 2016 were generic versions of Gleevec (imatinib), Glumetza (metformin ER tablet), Enablex (darifenacin), Tamiflu (oseltamivir), Nuvigil (armodafinil), Seroquel XR (quetiapine ER tablet), and Crestor (rosuvastatin). First-time generic launches scheduled for 2017 include Viagra (sildenafil) and Norvir (ritonavir 100 mg tablet).

    Novel drugs did not fare as well as generics approvals. New molecular entity (NME) and new biologic license application (BLA) filings have been relatively flat since 2011, with 22 of 41 NME or BLA filings approved.

    Notably, 86% of new products approved by the FDA in 2016 have not yet been approved in other countries, Kao said.

    Expedited FDA approval program plays dominant role

    Expedited FDA approval programs played a dominant role in new-drug approvals.

    “Seventy three percent of novel new drugs had at least one method of expedited approval,” Kao said.

    • 36% were fast-tracked as drugs that fill an unmet medical need for serious conditions;
    • 27% were granted accelerated approval as drugs for serious conditions filling unmet need based on surrogate trial endpoints; and

    • 32% were designated breakthrough therapies.

    • Fully 68% were granted priority review status as drugs that offer significant improvements over existing therapies, a designation that requires FDA action within six months.

    New brand drugs approved in 2016 included anti-infectives like PaxVax’s Vaxchora (cholera live vaccine), Merck Sharp & Dohme’s ZInplava (bezlotoxumab, for Clostridium difficile infection), Protein Sciences Corporation’s recombinant influenza vaccine Flublok Quadrivalent, and two influenza vaccines by Seqirus: the cell-culture Flucelvax Quadrivalent influenza vaccine and the egg-based influenza vaccine Afluria Quadrivalent.

    A new GSK shingles vaccine, Shingrix, is up for FDA approval in late 2017.

    Next: Pipeline 2017



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