견적문의

INGELHEIM, GERMANY--( / )--Boehringer Ingelheim today announced new presentations at the American Thoracic Society’s 2018 annual conference that reinforce the efficacy, safety and tolerability profile of OFEV® (nintedanib) in patients with idiopathic pulmonary fibrosis (IPF).

“The data presented at the conference support the established efficacy of OFEV®, while reaffirming the safety profile observed in the clinical trials and following approval,” said Christopher Corsico, M.D., Chief Medical Officer, Boehringer Ingelheim.

New IPF mortality analysis

Pooled data from the two Phase III INPULSIS® trials and the Phase II TOMORROW study compared the observed number of deaths in patients treated with nintedanib or placebo with the predicted rate of death based on GAP stage over one year.[1] GAP stage is used to predict IPF prognosis and is based on gender, age and lung function (as measured by forced vital capacity [FVC] decline % predicted and DLco % predicted).[1] Higher stages of GAP are associated with an increasing risk of death.[1]

Across the population (n=1,228), there were fewer deaths observed in each treatment group than predicted based on GAP stage at baseline (OFEV®: 42 vs. 89.9; placebo: 41 vs. 64.2).[1] In the OFEV® group, the number of observed deaths was 46.7% of the number predicted based on GAP stage, while in the placebo group the number of observed deaths was 63.9% of the number predicted.[1] Based on these differences, the analysis suggests that OFEV® may be associated with a 26.8% relative reduction in the risk of death compared with placebo over one year.[1]

“IPF is a progressive and fatal disease, and treatment with nintedanib can slow disease progression by reducing the rate of lung function decline,” said Christopher J. Ryerson, M.D., Assistant Professor at the University of British Columbia Centre for Heart Lung Innovation, Vancouver, Canada. “Although the individual trials were not powered to measure mortality, our pooled analysis suggests that nintedanib may offer a survival benefit for IPF patients.”

Lung function decline and quality of life

In a separate analysis of data from the INPULSIS® trials, a greater decline in lung function was associated with worsening patient-reported health-related quality of life (HRQoL) measuring respiratory function, shortness of breath, cough and sputum assessment and other quality of life measures.[2] Pooled data from patients treated with nintedanib or placebo showed that patients with a decline in FVC >10% predicted, regardless of treatment, experienced declines across different HRQoL measures.

“The symptoms of IPF can have a serious impact on a patient’s quality of life, resulting in a loss of independence and involvement in daily activities,” Michael Kreuter, M.D., Professor at the Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Care Medicine, University of Heidelberg, and a Member of the German Center for Lung Research, Germany. “Our analysis demonstrated an association between the extent of lung function decline and quality of life. Stabilizing lung function, therefore, may allow patients to retain some of their daily level of functioning, which might improve quality of life.”

Pooled safety data from six trials

Data from the largest set of OFEV®-treated patients with IPF analyzed to-date further confirmed its safety and tolerability profile.[3] The analysis included patients from six clinical trials (n=1,126), including TOMORROW, the two INPULSIS® trials, and their open-label extension studies.[3]

The average exposure to OFEV® was 27.7 months with a maximum exposure of 93.1 months, for a total of nearly 2,600 patient-years.[3] The rate of adverse events leading to permanent dose reduction (from 150 mg twice daily to 100 mg twice daily) or discontinuation from the studies were 12.8 and 23.8 events per 100 patient exposure-years, respectively.[3] Diarrhea remained the most common AE, and led to dose reduction or discontinuation in 17.2% and 8.8% of patients, respectively.[3] In the pooled data, the rate of diarrhea was lower than observed in the Phase III INPULSIS® trials.[3]

The corresponding abstracts can be found within the ATS online program, here:

Please click on the link below for ‘Notes to Editors’ and ‘References’:

Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business.

View source version on businesswire.com:Korea Newswire distributes your news across every media channels through the industry’s largest press release distribution network

INGELHEIM, GERMANY--( / )--Boehringer 봉남동홀덤펍 Ingelheim 출금수수료 today 출금수수료 골드드래곤 부작용 announced that the European 치바롯데마린스 INGELHEIM,has granted marketing authorisation for Cyltezo® a biosimilar to Humira® for the treatment of multiple chronic inflammatory diseases in 출금수수료 김연아세계선수권일정중계 adults and children.*

“Cyltezo® is the first biosimilar from Boehringer Ingelheim approved in Europe, and marks a significant step forward for us in offering effective, and more affordable treatment options for patients 봉남동홀덤펍 케토톱 with chronic 출금수수료 김연아해외반응동영상 inflammatory diseases,” said Ivan Blanarik, Senior Vice 출금수수료 마취크림 President and 출금수수료 김연아뱀파이어의키스해외해설 Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “Boehringer Ingelheim has been an industry leader in the production of biologics for 35 years, and we are delighted to have applied this expertise to the development of Cyltezo®. We believe biosimilars will be a key contributor to the future sustainability of healthcare systems around the world.”

Cyltezo® has been approved for 출금수수료 세계선수권대회피겨순서 the treatment 봉남동홀덤펍 김연아콧구멍하트 of multiple chronic inflammatory diseases in adults, including*:

· Moderate 축구만화 ·출금수수료 유출닷컴박시후 봉남동홀덤펍 유출닷컴박시후 severely active rheumatoid arthritis

코코메디가격 ·출금수수료 김연아의상디자이너 Psoriatic 출금수수료 김연아죽음의무도 arthritis 봉남동홀덤펍 김연아아사다마오의상비교

질싸닷컴 ·Moderate 봉남동홀덤펍 to severely active 봉남동홀덤펍 Crohn's 출금수수료 disease

· 봉남동홀덤펍 김연아허벅지 Severe 뉴야넷 ·봉남동홀덤펍 20mg ankylosing 출금수수료 김연아뒷태 spondylitis (AS) 출금수수료 5mg

· Moderate 봉남동홀덤펍 김연아뒤태 to severely active 봉남동홀덤펍 25mg ulcerative colitis 출금수수료 김연아노출모음 봉남동홀덤펍 김연아노출모음

· Severe axial 출금수수료 빅토리아노출움짤 소라걸스 ·출금수수료 복용법 without radiographic 출금수수료 필름형 evidence of AS 봉남동홀덤펍 김연아다리

· Moderate 출금수수료 to severe 출금수수료 봉남동홀덤펍 chronic 봉남동홀덤펍 손연재 plaque psoriasis 출금수수료 손연재노출모음

· 봉남동홀덤펍 도라에몽이슬이 Moderate 봉남동홀덤펍 500mg to severe 출금수수료 hidradenitis 봉남동홀덤펍 vgr220 suppurativa

· 봉남동홀덤펍 체조선수노출 Non-infectious intermediate, posterior and 출금수수료 이름 panuveitis.

Cyltezo® has also 봉남동홀덤펍 계열 been granted marketing authorisation for the treatment 출금수수료 of paediatric inflammatory diseases, including* moderate to severe Crohn's disease (age 봉남동홀덤펍 100미리 six and older), severe chronic plaque psoriasis (age four and older), enthesitis-related arthritis (age six 봉남동홀덤펍 한아름송이 60 Cyltezo®older) and polyarticular juvenile idiopathic arthritis (age two and older).

The marketing authorisation of Cyltezo® was based on a comprehensive data package supporting 봉남동홀덤펍 불티스 the biosimilarity of Cyltezo® 봉남동홀덤펍 발기부전치료제필름 to 출금수수료 얼짱시대7마지막회다시보기 야동TV Thecomprising analytical, pharmacological, non-clinical and clinical data.

This included results from the pivotal Phase 출금수수료 고두림화보 III study VOLTAIRE®-RA, which demonstrated clinical equivalence in efficacy 봉남동홀덤펍 정맥매복술 of BI 695501 to the reference product in patients with moderate to severely active rheumatoid arthritis by meeting its primary endpoint. Additionally the study showed 출금수수료 no 출금수수료 호피프릴비키니 봉남동홀덤펍 호피프릴비키니 clinically meaningful differences between BI 695501 and Humira® in terms of safety and immunogenicity.[3]

The Committee for Medicinal Products for Human Use 출금수수료 왕뽕프릴비키니 (CHMP) of the European Medicines Agency (EMA) adopted a positive 봉남동홀덤펍 스텐와이어 opinion 출금수수료 시알리스 100mg 복용법 for 봉남동홀덤펍 브래지어와이어 Cyltezo® on September 14th, 20171 and on August 25th, 2017, Cyltezo® was approved 봉남동홀덤펍 블랙와이어비키니 by the U.S. Food 출금수수료 와이어왕뽕비키니 and Drug Administration (FDA) in the United States 야동TV The[2]

Cyltezo® is not commercially 봉남동홀덤펍 available in 봉남동홀덤펍 아스피린 비아그라 Europe or 봉남동홀덤펍 자연산 비아그라 만드는 법 the U.S. at this time. In any event Boehringer Ingelheim does not intend to launch Cyltezo® in the EU before 출금수수료 아드레닌 지속시간 expiration of the 야동TV Cyltezo®SPC for adalimumab in October 2018. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie in the U.S.

Intended 출금수수료 센글라정50mg 실전포커껨 Intended봉남동홀덤펍 비닉스 가격

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended 출금수수료 to provide information about our global business. Please be aware that information relating 봉남동홀덤펍 비키니수영복추천 to the approval status and 출금수수료 labels of approved products may vary from 출금수수료 센글라 복용법 country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

For references 봉남동홀덤펍 발기강화 and 봉남동홀덤펍 수원비키니라인제모 notes to editors, 출금수수료 please 봉남동홀덤펍 남성호르몬보충 visit:

View source version 봉남동홀덤펍 연성방광내시경 on businesswire.com:Korea Newswire distributes 출금수수료 비키니라인제모가격 your news across 출금수수료 발기부전에좋은약 every media channels through the industry’s largest press release distribution network 출금수수료 남성성기능장애 봉남동홀덤펍 남성성기능장애