ちなみに
QMF149 (Atectura Breezhaler) が一足先に EUで承認されました。笑。

※AerzTezeitung: Asthma "EU Approval for Atectura Breezhaler". (6/15)
The European Commission has approved Atectura Breezhaler (indacaterol / mometasone furoate) as maintenance therapy for asthma for adults and adolescents aged 12 years and over.
Published: 2020/6/15
Nuremberg - The European Commission has granted approval for Atectura Breezhaler (indacaterol / mometasone furoate, IND / MF).
The once-in-a-time fixed combination of two, consisting of a long-acting beta2 agonist (LABA) and an inhaled corticosteroid (ICS), is indicated as maintenance therapy for asthma for adults and adolescents from 12 years of age,
who is treated with an ICS and inhaled, short-acting beta2 agonist (SABA) are not sufficiently controlled. IND / MF is used once a day in the Breezhaler inhaler.
The approval includes the IND / MF doses 125 μg / 62.5 μg, 125 μg / 127.5 μg and 125 μg / 260 μg.

The EU approval is based on the extensive data from the Phase III PALLADIUM and QUARTZ studies, which included around 3,000 patients with asthma.
The studies examined the efficacy and safety of IND / MF as part of the PLATINUM Phase III clinical development program.
In both studies, the primary endpoint, the superiority of IND / MF over MF monotherapy in the effect on lung function using Trough-FEV1, and the secondary endpoint, the superiority in effect on disease control using the asthma control questionnaire (ACQ- 7).
In the PALLADIUM and QUARTZ studies, IND / MF was significantly superior to ICS monotherapy with MF in improving lung function and asthma control (p <0.001).
In further analyzes of the PALLADIUM study, a significant improvement in lung function under IND / MF compared to the LABA / ICS therapy standard consisting of salmeterol / fluticasone propionate (SAL / FLU) was also observed (p = 0.040).

In addition to the now EU approval for IND / MF, the first fixed triple combination Enerzair Breezhaler (IND / GLY / MF) to be applied once a day received an approval recommendation from the Committee for Medicinal Products for Human Use at EMA (CHMP) .
According to the recommendation, the combination is suitable for adult patients who are uncontrolled despite inhaled combination therapy consisting of LABA and high-dose ICS and who had at least one exacerbation in the previous year.

※European Commission procedures: "Atectura Breezhaler"
・Close date: "02 Jun 2020"
・Procedure type: "Centralised - Authorisation"
・EMA number: "EMEA/H/C/005067/0000"
・Decision number: "(2020)3660 of 30 May 2020"