-POSITIVE NEWS SEPTEMBER17 Sep 2017 15:08
Issued: London UK – LSE
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (for effects on symptom control see section 5.1). The proposed brand name is Trelegy Ellipta.
13 September 2017
FDA Advisory Committee votes unanimously for Shingrix (HZ/su) in the US for prevention of herpes zoster (shingles) in adults ages 50 and over
Issued: London UK – LSE
GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted unanimously that the data support the efficacy and safety of Shingrix for the prevention of herpes zoster (shingles) in adults ages 50 and over. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA.
12 September 2017
GSK announces phase III results published in NEJM of mepolizumab in patients with eosinophilic COPD at risk of exacerbations
- Regulatory filings planned for 2017
Issued: London, UK
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the publication of full results from the phase III studies for mepolizumab in chronic obstructive pulmonary disease (COPD). Data from the investigational clinical development programme showed that treating eosinophilic COPD patients with the biologic medicine, mepolizumab, in addition to maximal guideline-recommended therapy, reduced exacerbations in these difficult-to-treat patients. Based on the full data, discussions with external experts and the recognised unmet medical need in this patient population, regulatory filings are planned for 2017. Mepolizumab is not approved for use anywhere in the world for COPD.
11 September 2017
Positive results from pioneering Salford Lung Study in asthma published in The Lancet, and presented at European Respiratory Congress
Relvar Ellipta was superior to usual care treatment in improving asthma control for patients in Salford Lung Study.
Issued: London SEPTEMBER 2017
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced positive results from the Salford Lung Study (SLS) in asthma have been simultaneously published in The Lancet journal and presented at the European Respiratory Society (ERS) International Congress in Milan.
The innovative study, which reported headline results in May 2017, showed that initiation of once-daily Relvar Ellipta (fluticasone furoate ‘FF’/vila