Date: 2017-09-18
Type of information: Granting of a Market Authorisation in the US
Product name: Trelegy Ellipta®
Compound: fluticasone furoate/umeclidinium/vilanterol
Therapeutic area: Respiratory diseases
Action mechanism:
- corticosteroid/long-acting beta2-agonist (LABA)long-acting muscarinic antagonist (LAMA). This treatment combines an inhaled corticosteroid (fluticasone furoate); a long-acting muscarinic antagonist (umeclidinium); and a long-acting beta2-adrenergic agonist (vilanterol), all delivered in GSK's Ellipta inhaler.
- Both umeclidinium and vilanterol act locally to produce
bronchodilatation by separate mechanisms . Umeclidinium exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic receptors on airway smooth muscle. Vilanterol stimulates the enzyme catalysing AMP into cyclic AMP leading to relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells.
Fluticasone furoate is a corticosteroid and reduces inflammation.
Company: GSK (UK)
Disease: maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting ?2-agonist
Latest news:
- • On September 18, 2017, GSK and Innoviva announced that the FDA has approved once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), under the brand name Trelegy Ellipta®, for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or for patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol. Trelegy Ellipta® is not indicated for relief of acute bronchospasm or the treatment of asthma.
- This is the first once-daily product approved in the US that combines three active molecules in a single inhaler for the maintenance treatment of appropriate patients with COPD. The FDA-approved strength is FF/UMEC/VI 100/62.5/25 mcg.
- • On September 15, 2017, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorisation for FF/UMEC/VI as maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. The proposed brand name is Trelegy Ellipta®.
- Trelegy Ellipta® is the first once-daily single inhaler triple therapy to be granted a positive opinion by the CHMP. It will be available as 92 µg / 55 µg / 22 µg Inhalation powder, pre-dispensed. .
The benefits with Trelegy Ellipta® are its ability to improve lung function (as defined by change from baseline trough FEV1 at Week 24; co-primary endpoint) compared with budesonide/formoterol (BUD/FOR) 400/12 micrograms administered twice-daily in moderate to severe patients not adequately controlled with corticosteroid and long acting ? agonist. The most common side effects are nasopharyngitis (7%), upper respiratory tract infection (2%) and headache (5%).
• On December 2, 2016, GSK and Innoviva announced the filing by GSK of a regulatory submission with the European Medicines Agency for once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) for patients with chronic obstructive pulmonary disease (COPD). The EU regulatory submission is based on data from the closed triple combination therapy development programme including data from the phase III FULFIL study, as well as data from studies with FF, UMEC and VI either alone or in combination.
- • On November 21, 2016, GSK and Innoviva announced the filing by GSK of a regulatory submission with the FDA for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) for patients with chronic obstructive pulmonary disease (COPD). This follows the announcement earlier this year of plans to bring forward the timing of the US filing from the first half of 2018.
The US regulatory submission of the closed triple therapy comprises a New Drug Application for the maintenance treatment of patients with COPD, including chronic bronchitis and emphysema. It is based on data from the closed triple combination therapy development programme, as well as data from studies with FF, UMEC and VI either alone or in combination. A regulatory filing in the EU is planned in the coming weeks and is expected to be followed by submissions in other countries beginning in 2017.
Patents:
Submission of marketing authorization application USA : 2016-11-21
Submission of marketing authorization application UE: 2016-12-02
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-09-18
UE authorization:
Favourable opinion UE: 2017-09-15
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
