GSK’s and Theravance’s Relovair – Will it be a breath of fresh air or are there regulatory hurdles ahead?

Posted by lifetech on November 22nd, 2010

A few months ago, we reviewed indacaterol, a long-acting beta agonist (LABA) under development as monotherapy for chronic obstructive pulmonary disease (COPD). We revisit the LABA and respiratory spaces with a review of GlaxoSmithKline’s (GSK’s) and Theravance’s entrant – Relovair. In contrast to indacaterol, Relovair is a combination product. It combines vilanterol, a LABA, with fluticasone furoate, an inhaled corticosteroid (ICS). Respectively, both are analogs of salmeterol and fluticasone propionate, the components of Advair. In contrast to Advair, Relovair kinetics support once-daily administration, giving hope that it can effectively cannibalize the Advair market in advance of generic competition.

As with indacaterol, the effects of Relovair and its components seem consistent with their respective classes. However, a number of differences between the programs add layers of nuance to the regulatory prospects for Relovair, which we explore in depth in our report. Relovair is a combination LABA + ICS product and the sponsors are pursuing indications in both asthma and COPD (although with somewhat different regulatory strategies). Further, the programs differ enough that the ‘regulatory bumps in the road’ may not be the same for the two programs. Finally, FDA’s thinking around the complex issues related to LABA safety continues to evolve, sending mixed signals. Thus, Relovair provides a new reason and opportunity to look closely at this space again.