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As FDA continues to re-assess LABA safety, GSK's Relovair enters Phase III for asthma

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Despite FDA's continuing concerns about the safety of long-acting beta agonists, GSK is forging ahead with Relovair, a combination of a new long-acting beta agonist and an inhaled corticosteroid that is positioned as the successor to GSK's multi-billion dollar twice-daily LABA/ICS combo Advair (salmeterol/fluticasone propionate). Relovair combines two new molecular entities, the LABA vilanterol trifenatate (previously 642444) and the ICS fluticasone furoate. The first Phase III study in asthma kicked off in March 2010, and the company indicated that FDA's re-evaluation of LABA safety will be reflected in the process. "GSK is in ongoing discussions with FDA regarding the U.S. component of the global asthma program," the company stated in the March 19 announcement. FDA announced a restrictive class REMS in February, based on evidence suggesting that the LABAs can increase risk of severe asthma symptoms, hospitalization, or death (1"The Pink Sheet," Feb. 22, 2010). Discussion has been public, with multiple advisory committee meetings, most recently a March 10-11 meeting on LABA trial design (2"The Pink Sheet," March 22, 2010). The extent of the discussion could provide valuable guidance to GSK, enabling the design of trials that directly address the questions FDA wants asked. The Relovair program (formerly called HORIZON) is certainly shaping up to be extensive: the new Phase III asthma trial is an acute exacerbation study that will enroll 2,000 patients. GSK envisions a pivotal Relovair asthma program comprising eight trials, including head-to-head comparisons with Advair and its components, low- and high-dose combination studies, and an ongoing 12-month safety trial in 500 patients designed to support both asthma and chronic obstructive pulmonary disease claims. The parallel COPD Phase III program, which kicked off in October 2009, is similarly extensive; GSK predicted enrolling over 6,000 patients (3"The Pink Sheet" DAILY, Oct. 28, 2009). GSK developed Relovair under a 2002 collaboration with Theravance

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