GSK plans regulatory applications in Europe by mid-year for both indications.
GlaxoSmithKline (GSK) and Theravance are reporting mostly positive results from two studies for Relovair in chronic obstructive pulmonary disease (COPD) and asthma. Relovair met its primary endpoint in one of two replicate studies in COPD comparing it to Advair (also a GSK product); while it did not achieve statistical significance in one of the trials, it did demonstrate the ability to improve lung function. In the asthma study, Relovair and Advair were separately compared to placebo and both achieved the primary endpoint.
With these studies the companies have completed the registrational program for the drug. For COPD, GSK continues with its plans to submit regulatory applications in the U.S. and Europe in mid-2012. For asthma, GSK plans to submit an application in Europe in mid-2012 and will continue discussions with the FDA on the regulatory requirements for a U.S. asthma indication.
The COPD program comprised two replicate 12-week superiority studies evaluating the 24-hour lung function profile of once-daily Relovair (fluticasone furoate, or FF/vilanterol, or VI) 100/25 mcg compared with twice-daily Advair 250/50 mcg (fluticasone propionate, or FP/salmeterol, or SAL) in patients with COPD. Each study randomized approximately 500 patients.
In the first study, FF/VI demonstrated superiority over FP/SAL on the predefined primary endpoint of 0–24 hour weighted mean FEV1. In the second study, FF/VI demonstrated numerical improvements but not statistical superiority over FP/SAL on the predefined primary endpoint of 0–24 hour weighted mean FEV1. Across these two studies, the most common adverse events in the FF/VI arms reported were nasopharyngitis, headache, and oropharangeal candidiasis.
The asthma trial was a 24-week multicenter study of approximately 330 patients. FF met the primary endpoint of a statistically significant change from baseline in evening FEV1 at the end of the 24-week treatment period compared to placebo. FP also met this primary endpoint when compared to placebo (p=0.011). In this study, the most common adverse events on the FF arm were bronchitis, headache, nasopharyngitis, upper respiratory tract infection, pharyngitis, and sinusitis.
FF/VI is a long-acting beta2 agonist and glucocorticoid agonist. It is one of several late-stage assets in the GSK respiratory development portfolio, which includes LAMA/LABA (GSK573719/VI) and MABA (GSK961081), developed in collaboration with Theravance, as well as a FLAP-inhibitor (GSK2190915), a p-38 kinase inhibitor (losmapimod), and anti-IL5 MAb (mepolizumab). The Phase III program for LAMA/LABA is expected to complete in 2012.