Novartis sees low-dose Neohaler approval as important step

The once-daily Arcapta Neohaler by Novartis has been approved by the FDA for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, Pharmaceutical Business Review reports.

The Neohaler delivery device lasts for 24 hours and saves patients from the need to use daily "rescue" medication for their condition. However, as FierceBiotech reported, this approval was for only a 75 mcg dose. Novartis had been hoping to get the stronger 150 mcg dose approved so that it can set up its closely watched study of a new COPD treatment that combines a LABA and LAMA treatment.

Still, Novartis says it will adapt and welcomed the approval as "good news for patients." Reuters reports that, until recently, Novartis was not on the radar as a major force in lung drugs because of the difficult-to make inhaler devices required for delivery. Now, Reuters reports, "the field is emerging as pivotal to the company's future."

- read more at FierceBiotech
- Reuters filed this report
- and here's the news in PBR

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