On December21, 2017, GlaxoSmithKline plc issued a press release announcing that (i)it has received approval by the U.S. Food and Drug Administration (FDA) of labelling changes to remove the boxed warning from inhaled corticosteroid (ICS) / long-acting beta2 agonist (LABA) combination medicines, including BREO ELLIPTA (fluticasone furoate/vilanterol, FF/VI) and (ii)the FDA also approved updates to the Warnings and Precautions section of labelling for the ICS/LABA class.
BREO ELLIPTA has been developed under the LABA collaboration agreement between Glaxo Group Limited and Innoviva.
The information in Item 7.01 of this Current Report on Form8-K is being furnished and shall not be deemed filed for the purposes of Section18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
/s/ Eric dEsparbes
Chief Financial Officer
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