INNOVIVA,INC. (NASDAQ:INVA) Files An 8-K Regulation FD Disclosure

INNOVIVA,INC. (NASDAQ:INVA) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.

Story continues below

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.


Innoviva, Inc., formerly Theravance, Inc., focuses on bringing new medicines to patients in areas of unmet need. The Company is engaged in the development, commercialization and financial management of bio-pharmaceuticals. Its portfolio focuses on the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR/BREO ELLIPTA (fluticasone furoate/vilanterol (FF/VI)) and ANORO ELLIPTA (umeclidinium bromide/vilanterol (UMEC/VI)). It operates in providing capital return to stockholders by maximizing the potential value of its respiratory assets partnered with GSK segment. RELVAR/BREO is a once-a-day combination inhaled respiratory medicine consisting of VI, a LABA and FF, an inhaled corticosteroid (FF/VI) delivered via the ELLIPTA dry powder inhaler. ANORO ELLIPTA is a dual bronchodilator consisting of UMEC, a long-acting muscarinic antagonist (LAMA) and VI, a LABA for the treatment of chronic obstructive pulmonary diseases (COPD).

An ad to help with our costs