Fluticasone propionate/Salmeterol xinafoate

MONDAY, Aug. 7, 2023 -- For patients with chronic obstructive pulmonary disease (COPD), generic and brand-name fluticasone-salmeterol are similarly effective and safe, according to a study published online Aug. 8 in the Annals of Internal Medicine . William B. Feldman, M.D., D.Phil., from Brigham and Women's Hospital in Boston, and colleagues compared the effectiveness and safety of generic (Wixela Inhub) and brand-name (Advair Diskus) fluticasone-salmeterol among patients with COPD in a propensity score-matched cohort study. Of 27,305 Advair Diskus users and 18,064 Wixela Inhub users, 10,012 matched pairs were included in the primary analysis. The researchers found that Wixela Inhub use was associated with a nearly identical incidence of first moderate or severe COPD exacerbation compared with Advair Diskus (hazard ratio, 0.97; 95 percent confidence interval, 0.90 to 1.04) and with a similar incidence of first pneumonia hospitalization (hazard ratio, 0.99; 95 percent confidence interval, 0.86 to 1.15). "In patients with COPD, the generic inhaled corticosteroid-long-acting β-agonist Wixela Inhub had nearly identical effectiveness and safety when compared with brand-name Advair Diskus," the authors write. "Similar studies can provide a useful means of evaluating the clinical effectiveness and safety of complex generic products after approval." Abstract/Full Text (subscription or payment may be required) Posted August 2023

Headline results for the first quarter: Revenue: £7.2 billion ($9.3 billion), up 4% Profit: £1.7 billion ($2.3 billion), versus £975 million in the prior year Revenues grew 10% excluding sales of COVID-19 solutionsNote: All changes are versus the prior-year period unless otherwise statedWhat the company said:“We have delivered another excellent quarter of performance, with strong sales and earnings growth, notably in HIV and Vaccines, and continued strengthening of the R&D pipeline and product portfolio,” said CEO Emma Walmsley.GSK recently secured approval of Arexvy, the world’s first RSV vaccine, which Walmsley described as an important milestone for the company and reflective of the “next wave in vaccine innovation at GSK.”Walmsley added “our momentum supports the upgrade we have made to our financial guidance for 2023 and further increases our confidence in delivering longer-term profitable growth for shareholders.”Other results:Speciality medicines: £2.5 billion, down 7% HIV product sales: £1.6 billion, up 13% Dovato: £430 million, up 34% Triumeq: £392 million, down 15% Tivicay: £340 million, down 2% Cabenuva: £176 million, up >100% Oncology product sales: £151 million, down 2% Zejula: £117 million, down 3% Nucala: £424 million, up 16% Benlysta: £358 million, up 21%General medicines: £2.6 billion, up 5% Respiratory: £1.8 billion, up 9% Trelegy Ellipta: £611 million, up 31% Seretide/Advair: £322 million, up 23% Relvar/Breo Ellipta: £288 million, down 7% Vaccine sales: £2 billion, up 18% Shingrix: £880 million, up 20% Bexsero: £194 million, up 18% Menveo: £66 million, down 4%Looking ahead:GSK upgraded its full year guidance and now expects revenues to grow between eight and ten percent and adjusted operating profit to grow between 11% and 13% in 2023.What analysts said:In a note to inventors, Jefferies analyst Peter Welford wrote: “GSK offers robust double-digit EPS growth until HIV patent expiries and US Shingrix shingles vaccine saturation, but still likely needs in-licensing/bolt-ons to then sustain the business, particularly given recent setbacks in oncology. These longer-term fundamental challenges keep us on the sidelines, despite NPVs suggesting the current share price is deeply discounted. The Zantac US litigation overhang is 80%-plus cleared, but persists.” Pipeline updates:Potential filing of Blenrep in second-line multiple myeloma in US and EU now expected in the first half of 2024, as is the read out of Phase III data for Zejula in the FIRST study for ovarian cancer.($1 = £0.77518803)