Asmanex and Dulera Receive Expanded Indications
August 12, 2019 – The U.S. FDA has approved expanded indications for Merck’s Asmanex® HFA (mometasone furoate) and Dulera® (mometasone furoate, formoterol fumarate). Both medications are now approved to treat asthma in patients who are at least five years of age.
For Asmanex, recommended dose is two 100mcg or 200mcg inhalations twice daily for patients 12 years of age and up, and two 50mcg inhalations twice daily for patients at least five years of age and younger than 12 years. Dulera has a recommended dose of two 100mcg/5mcg or 200mcg/5mcg inhalations twice daily for patients who are at least 12 years of age. For patients aged five through 11 years of age, the recommended dose is two 50mcg/5mcg inhalations twice daily.
Approval for the expanded indications was based on clinical studies in which Asmanex HFA 50mcg was found statistically superior to placebo and Dulera produced a statistically significant change from baseline when compared to mometasone furoate (a single component of Dulera). Both Asmanex and Dulera demonstrated similar safety profiles in children as young as five years of age compared to those seen in patients 12 years of age and older.