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    Four therapeutic areas to watch in 2018



    Following on the heels of three COPD medications approved in 2017 is Sunovion’s SUN-101 (glycopyrrolate nebulization solution), a long-acting, muscarinic antagonist (LAMA) that allows for rapid administration of the product. Its approval is expected shortly after press time. AstraZeneca/Pearl also are planning a new product for COPD, a twice-daily, inhaled LAMA. 

    While triple therapy—a combination of an inhaled corticosteroid, a LAMA, and a long-acting beta agonist—shook the market in 2017, Peterson says that the largest impact on the market in 2018 could be the introduction of the first generic to Advair Diskus, a long-acting, beta agonist/inhaled corticosteroid. Sandoz’ generic is currently under FDA review with a possible approval in mid-2018, along with Advair generics from Mylan and Hikma/Vectura headed for the second half of 2018.

    At press time, AstraZeneca is awaiting approval of Daxas (roflumilast), which counteracts the effect of an enzyme that contributes to inflammation, due to its side effect profile. In November 2017, the company also received FDA approval for Fasenra (benralizumab), for severe eosinophilic asthma. It is the first respiratory biologic with an eight-week maintenance dosing schedule. Also being evaluated for COPD, benralizumab is expected to hit the market in first or second quarter 2018.

    “Benralizumab, however, doesn’t have the brand recognition that dupilumab does,” Lyle says, “even though it has proved equal in efficacy in clinical trials. Both drugs represent a new method of delivery as self-injectables, placing responsibility on patients and specialty pharmacies for adherence. Now that the door is open, there are likely to be me-too drugs in this space.”

    Lyle foresees that these drugs offer a value proposition and will land on formularies with prior authorization and step therapy.

    Mari Edlin
    Mari Edlin is a frequent contributor to Managed Healthcare Executive. She is based in Sonoma, California.


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