FDA gives OK to Novartis' Arcapta

The FDA has approved Novartis' once-daily Arcapta Neohaler (indacaterol inhalation powder) 75 mcg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with COPD. And according to a company release, the decision makes Arcapta--formerly known as QAB149--the first once-daily therapy in the long-acting beta2-agonist class to be approved in the U.S. for maintenance treatment of airflow obstruction in COPD patients.

Indacaterol was first approved in November 2009 in the EU as the Onbrez Breezhaler. It is now approved in more than 60 countries for the treatment of COPD and is available in more than 30 countries with additional launches planned this year. The Arcapta U.S. launch is planned for the first quarter of 2012.

As the Wall Street Journal notes, the FDA had blocked the approval of the indacaterol inhalation powder in 2009 because of safety concerns. Novartis agreed to investigate lower doses of the drug. Analysts have said approval of indacaterol is key for the continued development of the drugmaker's lung-medicine franchise.

- check out the Novartis release
- get the WSJ report

Suggested Articles

BMS’s Opdivo has plenty of competition in its current bladder cancer indication—so it’s hoping to strike out on its own in a new area of the disease.

The Japanese approval, under the brand name Jyseleca, came a month after an FDA complete response letter that asked Gilead for more data.

The Trump Administration has opened the doors for Florida and other states to import prescription drugs from Canada—despite industry objections.