FDA Approves Triple Therapy Dry Powder Inhaler
Background: Over the past several years, the United States Food and Drug Administration has approved numerous combination inhalers – two medications in a single inhaler for patients with COPD. These combinations include short-acting bronchodilators, four different long-acting bronchodilators, and three different long-acting bronchodilators along with an inhaled corticosteroid.
Combination inhalers are more convenient for patients than using two different inhalers. Also, there is only one co-pay with a single combination inhaler compared to two separate inhalers.
Announcement: On September 18, 2017, the FDA announced approval of a once-daily single inhaler triple therapy – three medicines in one – the brand name is Trelegy Ellipta.
This triple therapy inhaler consists of three medications that are approved in two different inhalers: 1. umeclidinium – muscarinic antagonist bronchodilator (brand name: Incruse); and 2. vilanterol (a beta2 agonist bronchodilator) combined with fluticasone furoate (an inhaled corticosteroid) (brand name: Breo).
Indications: The press release states that the FDA approves triple therapy inhaler – Trelegy Ellipta – for the “long-term, once-daily, maintenance treatment of patients with COPD” who are: 1. already taking vilanterol and fluticasone furoate (Breo Ellipta) in whom additional bronchodilation is desired; OR 2. Those currently taking both Incruse and Breo Ellipta inhalers.
Trelegy Ellipta is not indicated for the treatment of those with asthma.
The press release also stated that the medication “will be available in the US shortly.”
European Medicines Agency (EMA): On September 15, 2017, the EMA’s Committee for Medicinal Products for Human Use issued a positive opinion recommending marketing authorization for the same triple therapy inhaler approved by the FDA. The proposed brand name – Trelegy Ellipta – is subject to regulatory approval in Europe.
Trelegy Ellipta dry powder inhaler