- The FDA approved Novartis' Utibron Neohaler (indacaterol/glycopyrrolate) for chronic obstructive pulmonary disorder (COPD) last week, and the company plans to launch the therapy by Q1 2016.
- The FDA approval was based on the phase 3 EXPEDITION trial, which involved more than 2,600 patients and encompassed two 12-week efficacy studies.
- With Utibron, Novartis is entering a crowded market dominated by GlaxoSmithKline, which launched the first COPD combo treatment in the U.S., Anoro Ellipta, in 2014 as well as Advair followup Breo Ellipta. Other companies are planning to enter the market soon as well.
GSK was the first to market with a combo inhaler, but it has not lived up to analysts' expectations in terms of uptake. Right behind GSK, Boehringer Ingelheim and AstraZeneca are looking to move into the market with combo inhalers soon.
Novartis may be late to the party, but it is showing up with a great deal of confidence in its ability to compete in this market, which is expected to reach $14 billion by 2018. In phase 3 clinical trials, Novartis' therapy met all primary and secondary endpoints in terms of significantly improving lung function, while also improving breathlessness and quality of life.