GSK has more mixed PhIII Relovair data for COPD, but submissions remain on track
This article was originally published in Scrip
GlaxoSmithKline and its partner Theravance have put forward additional mixed Phase III top-line data for once-daily Relovair, a drug containing fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2 agonist (LABA) - this time in two non-pivotal trials for treatment of chronic obstructive pulmonary disease (COPD).
The COPD top-line data showed that once daily Relovair beat GSK's top-selling drug Advair in a breathing test in only one of the two studies but not the other.
In January 2012, the market showed displeasure upon mixed news from Phase III COPD data, wiping some $3 billion from GSK's market value (scripintelligence.com, 10 January 2012). The latest data brought a more muted reaction. Theravance closed on 23 March up 4.6%, or $0.85, to $19.47 while GSK fell on the news on 23 March from £14.25 to close at £14.10, lower than its price after the January fall.
Relovair, as a once-daily drug, was expected to be the successor in COPD to GSK's top selling twice-daily treatment Advair (fluticasone propionate/salmeterol: Seretide in the EU). Once-daily dosing – rather than any substantial improvement in efficacy or safety over Advair – is the reason analysts and investors believe Relovair could find a market.
All the pivotal Phase III trials have now been completed for both the COPD and asthma indications of Relovair. GSK and Theravance remain on schedule to file for approval in the US and Europe for COPD by mid-2012.
For asthma, GSK plans to submit an application in Europe in mid-2012, and will continue discussions with the FDA. The consensus of analysts is that since the FDA has ongoing concerns about LABA safety, it will be more difficult for a firm to gain clearance of a new asthma drug in the US containing a LABA.
As long as GSK and Theravance report some Phase III successes for COPD treatment, the programme remains on target.
Repeatedly, GSK and Theravance emphasise that regulators will be expected to review the "totality" of the data package.
The two companies probably have some time in which to ensure that Relovair gains significant market share from Advair before Advair gets faces competing NCEs or generics. (While Advair faces US patent expiry this year, it might not face generic competition for some time. GSK has said that it is increasingly confident that Advair will escape serious generic competition in Europe in the near term.)
study headlines
Two replicate 12-week 500-patient superiority studies evaluated the 24-hour lung function profile of Relovair 100/25mcg compared to twice-daily Advair 250/50mcg in COPD patients using the measure of forced expiratory volume in one second (FEV1). In one study, Relovair was better than Advair (p<0.001) but="" in="" the="" second,="" relovair="" demonstrated="" numerical="" improvements="" but="" without="" statistical="" significance="" (p="">
It is the 100/25mcg dose of Relovair that GSK will seek approval for in its regulatory filing.
The two companies also pointed to results of a study for the asthma programme that represents the last Phase III trial for registration. That trial was designed to evaluate the efficacy and safety of fluticasone furoate and fluticasone propionate compared to placebo in the treatment of persistent asthma in adults and adolescents. In the 330-patient, 24-week study fluticasone furoate met the primary endpoint of a statistically significant change from baseline in trough evening FEV1 at the end of the 24-week treatment period (p=0.009) compared to placebo. Fluticasone propionate also met this primary endpoint when compared to placebo (p=0.011).
Datamonitor analysts believe that, if approved, Relovair has the potential to address the need for simplified treatment, which is particularly high for the elderly COPD population. Relovair may also address unmet needs through its novel inhaler designed as a next-generation inhaler. (The current Advair inhaler is delivered through GSK's Diskus device, which is an intricate device.)