Jan 20, 2019 | Updated: 08:39 AM EST

Novartis Seeking Approval for Medication to Treat 'Smoker's Cough'

Jan 09, 2015 09:29 PM EST


Novartis AG, a Swiss drug maker, is seeking U.S. regulatory approval for two new drugs designed to treat chronic obstructive pulmonary disease (COPD), otherwise known as "smoker's cough".  Approval of the drugs could generate an additional $1.4 billion for the company, while helping chronic smokers breathe a little clearer in the process.

Third-phase clinical tests for both QVA149 and NVA237 showed "positive" results for treating the disorder, the company said in a recent statement.

"These data once again confirm the strong efficacy and favorable safety profiles of both QVA149 and NVA237" global development head for Novartis Pharmaceuticals, Vasant Narasimhan says. "With submissions to the US 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."

Drug makers have begun introducing new respiratory treatments for COPD and other respiratory problems, as companies lose intellectual property rights on existing medications. But with two new products in the works, Novartis is seeking approval for both products as twice-daily treatments, which may place them at a disadvantage to once-a-day treatments such as GlaxoSmithKline's Anoro and Boehringer Ingelheim GmbH's Spiriva, analysts say.

"We believe this could limit the commercial potential of the products given the availability of once-daily alternatives," analysts with Barclays Plc say.

Both drugs have already received approval in Europe as once-daily treatments, but were delayed in the U.S. due to safety concerns of the Food and Drug Administration (FDA).  If approved, the company expects combined sales of approximately $1.4 billion by 2017. 

Chronic Obstructive Pulmonary Disease (COPD) kills a person every ten seconds and is estimated to become the third leading cause of death worldwide by 2030, according to the World Health Organization.

COPD is a progressive disease that makes it hard for sufferers to breathe.  Over time the condition worsens and leads to coughing that produces large amounts of mucus, wheezing, shortness of breath, chest tightness, and other symptoms. 

Cigarette smoking is the leading cause of COPD, and most people suffering from the disease are smokers or used to smoke.  Other common causes of the disease are long-term exposure to lung irritants such as air pollution, chemical fumes, or dust.

Although there is no cure for COPD, you can slow down the progression of the disease by quitting smoking and using treatments such as the drugs from Novartis.  According to the Centers for Disease Control, approximately 12 million people in the United States have been diagnosed with COPD.

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