GlaxoSmithKline's Scores FDA Approval For First IL-5 Inhibitor In Nasal Polyps

  • The FDA approved GlaxoSmithKline Plc's GSK Nucala (mepolizumab) for chronic rhinosinusitis with nasal polyps, making it the first IL-5 inhibitor to break into the indication.
  • The approval comes as an add-on maintenance therapy for adults with inadequate response to nasal corticosteroids.
  • The approval marks Nucala's fourth in eosinophilic-driven diseases.
  • The FDA based its approval on results from the phase 3 SYNAPSE study, which pitted Nucala against placebo in more than 400 patients.
  • In the 52-week trial, 57% fewer patients on Nucala needed surgery versus those in the placebo arm, GSK noted. Fewer patients on Nucala needed systemic corticosteroids, too. 
  • The drug also cut the size of nasal polyps and nasal obstruction over the 52 weeks.
  • Price Action: GSK shares are down 0.5% at $39.92 during the market session on the last check Friday.
  • Related content: Benzinga's Full FDA Calendar.

Posted In: BriefsNasal PolypsRhinosinusitisBiotechNewsHealth CareFDAGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on Bankrate.com. The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the Bankrate.com rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.