Novartis AG Submits Two Lung Drugs for FDA Approval; Analysts Question Decision

January 8, 2015
Novartis submits two new COPD drugs for approval as twice-daily treatments; Analysts question decision
By Jessica Wilson, BioSpace.com Breaking News Staff

Swiss drugmaker Novartis today announced that two of its drugs used to treat chronic obstructive pulmonary disease (COPD) have met the primary endpoints in their respective Phase III trials. Novartis submitted to U.S. Food and Drug Administration (FDA) New Drug Applications for both drugs, known as QVA149 and NVA237, in the fourth quarter of 2014.

“These data once again confirm the strong efficacy and favorable safety profiles of both QVA149 and NVA237,” said Vasant Narasimhan, global head of development at Novartis Pharmaceuticals in a statement. “With submissions to the U.S. FDA now complete for both treatments, we are closer to offering US patients with COPD a broader range of treatment options to help improve the significant burden of reduced lung function, and to help improve their lives.”

Both drugs are already approved for use outside the U.S. The drug QVA149, also known as indacaterol/glycopyrronium bromide, has been submitted to the US for approval as a twice-daily treatment. Outside the U.S., however, QVA149 is marketed as Ultibro Breezhaler, a once-daily maintenance bronchodilator treatment. The same is true for NVA237, also known as glycopyrronium bromide, which is sold outside the U.S. as a once-daily treatment called Seebri Breezhaler, but which has been submitted for approval to the FDA as a twice-daily treatment.

The decision to apply for approval of both products as twice-daily treatments has been questioned by analysts. Both GlaxoSmithKline and Boehringer Ingelheim GmbH currently sell once-daily treatments for COPD. According to Bloomberg Businessweek, analysts from Barclays Plc weighed in on Novartis’ decision today. “We believe this could limit the commercial potential of the products given the availability of once-daily alternatives,” the analysts were quoted as saying by Bloomberg Businessweek.

Still, Bloomberg estimates the two drugs could produce $1.4 billion in sales by 2017. The World Health Organization (WHO) estimates 210 million people suffer from COPD worldwide. The disease is now the third leading cause of death in the US and worldwide. The primary cause of COPD is tobacco, according to WHO, especially in middle-high income countries. In low-income countries, indoor air pollution, often caused by fuels for cooking, is the leading cause.

COPD is characterized by a cough that produces large amounts of mucus and by wheezing, shortness of breath, and chest tightness, according to the National Health, Lung and Blood Institute, a division of the U.S. National Institutes of Health.