FDA Delays Novartis Treatment

Recently, Novartis AG (NVS - Snapshot Report) announced that it has received a Complete Response Letter (CRL) for QAB149 (indacaterol) − a bronchodilator for the treatment of adults suffering from chronic obstructive pulmonary disease (COPD) − from the US Food and Drug Administration (FDA). The US agency has asked for additional information on the proposed dosing of the drug. Novartis had filed for the US approval of the drug in December last year. 

Last month, the Committee for Medicinal Products for Human Use (CHMP) recommended the approval of QAB149 in the European Union to treat COPD patients as a once-daily therapy with two doses (150 micrograms and 300 micrograms). The positive opinion from the CHMP is a boost to Novartis as it aims to be a strong player in the field of respiratory medicine. Currently, the market is dominated by big players such as GlaxoSmithKline (GSK - Analyst Report), AstraZeneca (AZN - Analyst Report) and Pfizer (PFE - Analyst Report). 

Management believes that it will be able to satisfy the queries of the US agency which will enable the dug to be approved in the US. On approval, Novartis initially intends to sell the respiratory drug as a monotherapy. However, we believe the drug has to be sold in combination with other treatments if it is to realize its full blockbuster potential. With this objective, Novartis is studying combinations of the drug with various other therapies though these combinations are unlikely to hit the market before 2013. 

The market for COPD, which affects 210 million people globally, is growing. According to the World Health Organization, the disease is expected to become the third leading cause of death globally by 2030. In excess of 12 million people are diagnosed with COPD in the US. It is the fourth leading cause of death in the country.