FDA approves low dose of Novartis lung drug

Posted: 7/1/2011

From Reuters:

U.S. health regulators on Friday approved a new lung medicine by Novartis (NOVN.VX), but in a lower dose, creating a roadbump for the Swiss drugmaker in its development of a potentially lucrative new drug.

In line with its advisory panel's vote in March, the U.S. Food and Drug Administration approved a 75 mcg dose of Arcapta Neohaler, an inhalation powder indacaterol for treating chronic obstructive pulmonary disease (COPD), which is also known as smoker's cough and is the third-leading killer of Americans.

Indacaterol is a once-a-day, long-acting beta agonist, or LABA, a type of drug used to open airways in patients with asthma or COPD. Other LABAs are taken twice a day. Such drugs carry a strong warnings about worsening of asthma and deaths in some patients.

Novartis and Glaxo are racing to sell a two-in-one medicine that combines a LABA with long-acting muscarinic antagonist (LAMA) to produce a more effective, convenient therapy.

For Novartis to develop such a drug, it needed approval for a higher 150 mcg dose of Arcapta Neohaler, which is sold as a a single therapy in Europe under the brand name Onbrez Breezhaler and had revenue of $33 million in 2010.

The 150 microgram dose of Arcapta Neohaler failed to win support from a U.S. advisory panel earlier this year as it urged Food and Drug Administration approval of a 75 microgram dose of the inhaled drug, unconvinced that the higher dose provided any additional benefit. [ID:nN08194906]

Novartis set up the trial for its combination drug using the higher dose of Onbrez, although the company has said it could adapt this if the U.S. only approves the lower dose, meaning any delay would be minimal.

Earlier on Friday, the way was cleared for Onbrez in Japan, and it is now approved in more than 60 countries. [ID:nLDE7601BY] Novartis said it planned to launch Arcapta in the United States in the first quarter of 2012.

Until recently, Novartis was not on the radar as a major force in lung drugs, which are difficult to make because of the inhaler devices they require for delivery.

Now the field is emerging as pivotal to the company's future through the drive into new branded drugs plus work with partner Vectura (VEC.L) on generic copies of products like GlaxoSmithKline Plc's (GSK.L) (GSK.N) Advair and AstraZeneca's (AZN.L) Symbicort.

COPD is known as smoker's cough because smoking is the major cause. The disease causes breathing trouble and chronic coughing and is sometimes fatal. An estimated 80 million people worldwide have moderate to severe COPD, according to the World Health Organization.

The FDA was due to release its final decision about Novartis's drug on April 1, but requested an extra three months to review the drug's effectiveness.

Original here.