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    • GSK Nucala wins USFDA...

    GSK Nucala wins USFDA approval for two new self-administration options

    Farhat NasimBy Farhat NasimPublished On 2019-06-09T10:00:05+05:30  |  Updated On 2021-08-16T11:16:31+05:30

    Nucala is the first anti-IL5 biologic to be licensed in the US for at-home administration, and the first respiratory biologic to be approved for administration via an autoinjector.


    New Delhi: GlaxoSmithKline recently announced that the US Food and Drug Administration (USFDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe, for patients or caregivers to administer once every four weeks after a healthcare professional decides it is appropriate.


    This is the first anti-IL5 biologic to be licensed in the US for at-home administration, and the first respiratory biologic to be approved for administration via an autoinjector.


    This approval will give healthcare professionals and people living with severe eosinophilic asthma (SEA) or the rare disease eosinophilic granulomatosis with polyangiitis (EGPA) the option for Nucala to be administered outside of a clinical setting by a patient or caregiver after their healthcare professional agrees this approach is appropriate. The original lyophilised powder version remains available for administration by a healthcare professional.


    Commenting on the approval,Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said, "Nucala's efficacy is well-established and this approval means that, for the first time, we are able to provide patients living with these debilitating conditions the option of receiving this important medicine in their own home."


    The approval is supported by positive patient experience data from two open-label, single-arm, phase IIIa studies (NCT03099096 & NCT03021304) evaluating the real-world use of Nucala administered via the new options in-clinic and at home by patients with SEA, or by their caregivers.


    Both studies showed patients were able to successfully self-administer treatment with both the autoinjector and pre-filled syringe after appropriate training (89-95% and 100% respectively). In addition, the majority of patients preferred at home self-administration options compared to in-clinic administration.


    A further open-label, parallel-group, single-dose study (NCT03014674) confirmed that the pharmacokinetic and pharmacodynamic profile of Nucala administered via pre-filled syringe or autoinjector was comparable to the originally approved lyophilised formulation.


    Tonya Winders, President, Global Allergy and Asthma Patient Platform (GAAPP), added, "People living with conditions like severe asthma often struggle to control their day-to-day symptoms, making routine activities like attending healthcare appointments a challenge. Empowering patients to take their medicines at home is an approach that has been successful in other chronic diseases such as diabetes and rheumatoid arthritis. GAAPP welcomes this approval for Nucala so it can be administered in a doctor's office or in the convenience of a patient's home."


    Following this approval, it is expected that the new administration options for Nucala will be available in the US shortly.


    Also Read: GSK's severe pediatric asthma drug wins European panel thumbs-up

    anti-IL5 asthma autoinjector breathing problem caregivers eosinophilic asthma Eosinophilic Granulomatosis GAAPP GlaxoSmithKline Global Allergy GSK Healthcare healthcare professionals lyophilised powder mepolizumab Nucala Nucala administered pre-filled syringe rare disease respiratory biologic SEA 

    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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