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Alan Khadavi, MD, APC
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May 30, 2017 by Alan Khadavi

Trelegy, New Asthma Triple Therapy to be Released by GSK

Trelegy, a new asthma medication by GlaxoSmithKline (GSK) is currently being developed for the treatment of asthma and COPD.  Trelegy will consist of 3 medications, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI).  The ingredients are an inhaled steroid, a long acting muscaranic antagonist and a long acting beta-agonist.  The medication will be delivered once daily as a dry powder inhaler.

Currently on the market there are only combination medications that have an inhaled steroid and long acting beta agonist, examples are Advair, Symbicort, Dulera and Breo.  Recent studies have shown that adding a long acting muscaranic antagonist is beneficial in some asthmatic patients.

Spiriva Respimat for Add-on Asthma

GSK is not the only company developing an asthma triple therapy combining an inhaled corticosteroid (ICS), long-acting beta-agonist (LABA) and a long-acting muscarinic antagonist (LAMA).  A study called TRINITY is combining beclometasone diproprionate (BDP),  formoterol fumarate (FF), glycopyrronium bromide (GB).  The brand name of this medication has yet to be determined.  The name Trelegy is still not the official brand name of the new closed triple combination COPD/asthma product by GSK, it is still subject to change.  Ironically a study called TRILOGY by another asthma drug manufacturer was looking into their own triple combination asthma/COPD product looking into the efficacy of using a steroid, LABA and a LAMA.  The company’s name is Chiesi.

Using a muscaranic antagonist such as umeclidinium, glycopyrronium bromide or tiotropium for patients with COPD has been well recognized over the years but for asthmatic patients it has only been recognized over the last few years.  It can be a bit cumbersome to use separate inhalers for some patients.  When Advair came out years ago it was revolutionary in that it combined an inhaled corticosteroid and long acting beta-agonist.  We now know that many asthma patients will benefit from using a long acting muscaranic inhaler, combining that with existing combination therapies will help get asthma patients get better control.  GSK expects Trelegy to be the first one to come to the market.  There are currently 6 companies doing research to come up with a triple therapy, they are all in different stages of research.  The cost of these combination medications still has yet to be determined.

http://aedestra.com/blog/inhaled-triple-therapy-who%E2%80%99s-bothering

Always speak to your asthma doctor to see which therapy is right for you.  Trelegy or any triple combination asthma medication would be most appropriate for moderate to severe asthmatic patients.  Mild intermittent patients, those who have symptoms infrequently would benefit from as needed albuterol.  If symptoms become more persistent your doctor may use an inhaled steroid.  If the asthma is still not controlled, adding a LABA is an option.  If all of that doesn’t work, a combination medication like Trelegy would be a possibility.  This past year, 2 new biological medications have come to the market for more severe asthmatic patients, Nucala and Cinqair.

New Asthma Drug Nucala (Mepolizumab) for Severe Eosinophilic Asthma

Cinqair (Reslizumab) for Eosinophil Disorders (formerly Cinquil)

Utibron was recently approved for COPD.  It is a combo LABA/LAMA consisting of indacaterol and glycopyrrolate and its for chronic bronchitis and/or emphysema.  It is being manufactured by Sunovion.  It does not have the indication for asthma. More than likely an inhaled corticosteroid would have to be added to it to be make a triple therapy to get the asthma indication.  Using a long acting beta-agonist and/or long acting muscaranic antagonist alone is not sufficient to control asthma symptoms.  In fact using a LABA has a black box warning of increased deaths from the FDA.

Update 9/20/17

Trelegy Ellipta received FDA approved for its triple therapy (LABA, LAMA and steroid) for COPD only, not asthma.  It is only indicated for COPD, but it is up to a physician what he/she could use a medication for.  Physicians can use a medication for an “off label” indication if they feel it would help a patient, but the safety and efficacy has not been established in the asthma population.  GSK who makes Advair which is approved for asthma, contains a steroid and a LABA.  As discussed earlier, some asthma patients may benefit from a LAMA.  If you suffer from asthma, speak to your asthma doctor about which medication is right for you.  Side effects listed are, headache, back pain, dysgeusia, diarrhea, cough, oropharyngeal pain, and gastroenteritis.

Update September 16, 2020: Trelegy is now approved for asthma. There are 2 doses the 200 and 100 which is the dose of the fluticasone furoate. It is essentially Breo with vilanterol.

FDA approves new asthma indication for Trelegy Ellipta.
It is the first single triple therapy inhaler in the U.S. approved for COPD and asthma.

Filed Under: Asthma, Blog

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Dr. Alan Khadavi
Allergy & Asthma Specialist

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