786206132-00X Timeline V5 · 2015. 11. 30. · with chronic obstructive pulmonary disease (COPD)...
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1921 1941 1975 1985 1995 2002 2003 2004 2005 2008 2011 2011 2011 2012 2013 2013 2013 2014 2014 2014 Development of tiotropium bromide begins Launch of Combivent ® MDI (ipratropium bromide and salbutamol) for the treatment of COPD † First launches of Spiriva ® in COPD take place in several European and Asian countries ¶ Spiriva ® recognised by GOLD, alongside other long-acting bronchodilators, as a first-line maintenance therapy for COPD 1 Spiriva ® becomes the world’s most prescribed COPD maintenance treatment 9 Landmark UPLIFT ® (Understanding Potential Long-Term Impacts on Function with Tiotropium) trial results demonstrated the long-term impact of Spiriva ® on COPD 10 Enrolment commences in the TOviTO ® Phase III clinical trial programme investigating the efficacy and safety of tiotropium/olodaterol delivered via Respimat ® in COPD On October 7th 2011 the FDA approved Combivent ® Respimat ® for the treatment of COPD Nintedanib receives orphan medicinal product designation from the European Commision in IPF × OFEV ® (nintedanib) becomes the first FDA-approved treatment for IPF Striverdi ® Respimat ® (olodaterol) is launched as a new once daily, COPD maintenance treatment. Striverdi ® , a unique and effective long-acting beta2- agonist with a fast onset of action 13 , has been specifically designed to complement the efficacy of Spiriva ®± Boehringer Ingelheim Respiratory Research & Development Timeline Aludrin ® is launched, an anti-asthmatic treatment breaking new ground in asthma treatment Lobelin ® (lobelin), the first stimulant-based respiratory product, is introduced as an emergency drug for arrested breathing Atrovent ® (ipratropium bromide) aerosol is launched, a short-acting anti-cholinergic for the treatment of patients with chronic obstructive pulmonary disease (COPD) Respimat ® launches. Respimat ® actively § delivers a unique mist, meaning the patient just needs to take a slow deep breath 2–8 Results from TIOSPIR ® (TIOtropium Safety and Performance In Respimat ®) – a landmark global trial in more than 17,000 patients, one of the largest COPD trials ever conducted 12 – confirm similar safety and efficacy of Spiriva ® HandiHaler ® and Spiriva ® Respimat ® Pivotal Phase III TONADO ® studies were announced at the European Respiratory Society Congress in Munich. The study results show tiotropium/ olodaterol provides significant improvement in lung function, breathlessness, quality of life and reduction in use of rescue medication over Spiriva ® Respimat ®15 Results from Phase III INPULSIS™ trials show investigational therapy nintedanib significantly slows disease progression in patients with idiopathic pulmonary fibrosis (IPF) compared to placebo 14 Phase III data show tiotropium Respimat ® as add-on to at least ICS/LABA significantly reduces risk of severe asthma exacerbations in adult asthma patients who continue to experience symptoms despite ICS/LABA POET-COPD ® (Prevention Of Exacerbations with Tiotropium in COPD) trial results show significant reduction of risk of exacerbation with Spiriva ® versus the LABA salmeterol 11 * Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF ® and in the U.S. under the brand name GILOTRIF ® for use in patients with distinct types of EGFR mutation-positive NSCLC. Registration conditions differ internationally, please refer to locally approved prescribing information. Afatinib is under regulatory review by health authorities in other countries worldwide. Afatinib is not approved in other indications. ** Nintedanib is approved in the EU under the brand name VARGATEF ® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. Nintedanib is under regulatory review by health authorities in other countries outside the EU. Nintedanib is not approved in other oncology indications. † Ipratropium bromide/salbutamol is approved under the brand name Combivent ® in the US, Canada and Mexico. ¶ Tiotropium is approved in the EU under the brand names Spiriva ® HandiHaler ® and Spiriva ® Respimat ® as a maintenance bronchodilator treatment to relieve symptoms of patients with COPD. § Respimat ® delivers a metered dose of medication in a mist at the push of a button requiring just a slow deep breath from a patient. × Nintedanib is approved under the brand name OFEV ® in the US, EU, Japan and other territories for use in patients with IPF. ± Olodaterol is approved under the brand name Striverdi ® Respimat ® in the EU and US as a maintenance bronchodilator treatment in patients with COPD. ¢ Tiotropium is approved in the EU under the brand name Spiriva ® Respimat ® as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800 μg budesonide/day or equivalent) and long-acting β2 agonists and who experienced one or more severe exacerbations in the previous year. Spiriva ® Respimat ® is approved in Japan for the relief of various symptoms associated with the obstructive impairment of airways due to bronchial asthma (only use for patients with severe persistent asthma). # Combined figures for HandiHaler ® and Respimat ® ‡ Tiotropium/olodaterol is approved under the brand name Spiolto ® Respimat ® in the EU as a once-daily maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Spiolto ® Respimat ® is registered as Stiolto™ Respimat ® in the US. þ Spiriva ® Respimat ® is approved by the U.S. Food and Drug Administration (FDA) for the long-term, once-daily, prescription maintenance treatment of asthma in people ages 12 and older. Spiriva ® Respimat ® is not indicated for the relief of acute bronchospasm. For further Boehringer Ingelheim media information please visit http://newscentre.boehringer-ingelheim.com/ 2014 Phase III data showed tiotropium Respimat ® in asthma as add-on to at least ICS/LABA maintenance therapy significantly improved asthma symptom control in adults 16 2014 Approval of Spiriva ® Respimat ® for use in asthma by regulatory authorities in the EU, Japan and many other countries ¢ 2012 Launch of Combivent ® Respimat ® (ipratropium bromide and albuterol) for the treatment of COPD 2015 To date, Spiriva ® has over 40 million patient-years # of real-life experience across all COPD severities 2015 Spiolto ® Respimat ® (tiotropium/ olodaterol) receives first European country approvals as a once-daily maintenance treatment to relieve symptoms in adult patients with COPD ‡ 2015 Approval of Spiriva ® Respimat ® for use in asthma in the US þ 2015 Once-daily Stiolto™ Respimat ® (tiotropium/olodaterol) Inhalation Spray is approved by US FDA as a long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema 2015 OFEV ® approved by the European Commission for the treatment of IPF 2015 OFEV ® included in the Updated International Treatment Guidelines for Idiopathic Pulmonary Fibrosis 17 2015 Inclusion of Spiriva ® Respimat ® in the updated GINA 2015 Global Strategy for Asthma Management and Prevention References: 1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of COPD. 2003. Available from: http://www.goldcopd.org/ 2. Newman SP, Brown J, Steed KP, et al. Lung deposition of fenoterol and flunisolide delivered using a novel device for inhaled medicines: Comparison of Respimat ® with conventional metered-dose inhalers with and without spacer devices. Chest 1998; 113: 957-963. 3. Pitcairn G, Reader S, Pavia D, et al. Deposition of corticosteroid aerosol in the human lung by Respimat ® Soft Mist ™ Inhaler compared to deposition by metered dose inhaler or by Turbuhaler ® dry powder inhaler. J Aerosol Med 2005; 18(3): 264-272. 4. Peterson JB, Prisk GK, Darquenne C. Aerosol deposition in the human lung periphery is increased by reduced-density gas breathing. J Aerosol Med Pulm Drug Deliv. 2008; 21(2): 159–168. 5. Dalby R, Spallek M, Voshaar T. A review of the development of Respimat ® Soft Mist ™ Inhaler. Int J Pharm 2004; 283: 1-9. 6. Zierenberg B. Optimising the in vitro performance of Respimat ® . J Aerosol Med 1999; 12 (Suppl 1): S19-S24. 7. Dalby RN, Eicher J, Zierenberg B. Development of Respimat ® SoftMist ™ inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl) 2011; 4: 145-155. 8. Anderson P. Use of Respimat ® Soft Mist Inhaler in COPD patients. Int J COPD 2006;1(3): 251–259. 9. Boehringer Ingelheim. Data on file. 10. Tashkin DP, Celli B, Senn S, et al. On behalf of the UPLIFT ® (Understanding Potential Long-term Impacts on Function with Tiotropium) study investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008; 359: 1543-1554. 11. Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011; 364(12): 1093-1103. 12. Wise RA, Anzueto A, Cotton D, et al. Tiotropium Respimat ® Inhaler and the Risk of Death in COPD: The Tiospir Trial. N Engl J Med 2013; 369(16): 1491-1501. 13. Ferguson GT, Feldman GJ, Hofbauer P, et al. Efficacy and safety of olodaterol once daily delivered via Respimat ® in patients with GOLD 2–4 COPD: results from two replicate 48-week studies. Int J COPD 2014; 9: 629-645. 14. Richeldi L, et al. Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis. N Engl J Med 2014; 370(22):2071-2082. 15. Buhl R, Maltais F, Abrahams R, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD2-4). Eur Respir J 2015; 45(4): 969-979. 16. FitzGerald JM, Kerstjens HAM, Paggiaro P, et al. Once-daily tiotropium Respimat ® add-on to ICS±LABA. Thorax 2014; 68(Suppl 2): A49-A50. 17. Raghu G, et al. An Official ATS/ERS/JRS/ALAT Clinical Practice Guidelines: Treatment of Idiopathic Pulmonary Fibrosis: Executive Summary. AJRCCM 2015; 192(2): 238-248.
Transcript of 786206132-00X Timeline V5 · 2015. 11. 30. · with chronic obstructive pulmonary disease (COPD)...
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2014
Development oftiotropium bromidebegins
Launch of Combivent®
MDI (ipratropium bromideand salbutamol)for the treatment ofCOPD†
First launchesof Spiriva® in COPDtake place in severalEuropean and Asiancountries¶
Spiriva® recognisedby GOLD, alongsideother long-actingbronchodilators, as afirst-line maintenancetherapy for COPD1
Spiriva® becomesthe world’s mostprescribed COPDmaintenancetreatment9
Landmark UPLIFT®
(UnderstandingPotential Long-TermImpacts on Functionwith Tiotropium)trial resultsdemonstratedthe long-termimpact of Spiriva®
on COPD10
Enrolment commencesin the TOviTO® PhaseIII clinical trialprogramme investigatingthe efficacy and safetyof tiotropium/olodateroldelivered via Respimat®
in COPD
On October 7th 2011the FDA approvedCombivent®
Respimat® forthe treatmentof COPD
Nintedanibreceives orphanmedicinalproductdesignationfrom theEuropean Commisionin IPF×
OFEV®(nintedanib)becomes the firstFDA-approvedtreatment for IPF
Striverdi® Respimat®
(olodaterol) is launchedas a new once daily,COPD maintenancetreatment. Striverdi®,a unique and effectivelong-acting beta2-agonist with a fast onsetof action13, has beenspecifically designedto complementthe efficacy of Spiriva®±
Boehringer Ingelheim Respiratory Research & Development Timeline
Aludrin® is launched,an anti-asthmatictreatment breakingnew ground in asthma treatment
Lobelin® (lobelin), thefirst stimulant-basedrespiratory product,is introduced as anemergency drug forarrested breathing
Atrovent® (ipratropiumbromide) aerosol islaunched, a short-actinganti-cholinergic for thetreatment of patientswith chronic obstructivepulmonary disease(COPD)
Respimat® launches.Respimat® actively§ delivers a unique mist, meaning the patient just needs to take a slow deep breath2–8
Results from TIOSPIR®
(TIOtropium Safety andPerformance In Respimat®)
– a landmark global trialin more than 17,000patients, one of thelargest COPD trialsever conducted12 – confirm similar safety and efficacy of Spiriva® HandiHaler® and Spiriva® Respimat®
Pivotal Phase IIITONADO® studies wereannounced at theEuropean RespiratorySociety Congressin Munich. The studyresults show tiotropium/olodaterol providessignificant improvement inlung function,breathlessness, qualityof life and reductionin use of rescuemedication overSpiriva® Respimat®15
Results from Phase IIIINPULSIS™ trials show investigational therapynintedanibsignificantlyslows disease progression in patients with idiopathic pulmonary fibrosis (IPF) compared to placebo14
Phase III data show tiotropium Respimat®
as add-on to at least ICS/LABA significantly reduces risk of severe asthma exacerbationsin adult asthma patients who continue to experience symptoms despite ICS/LABA
POET-COPD®
(Prevention OfExacerbations withTiotropium in COPD)trial results showsignificant reductionof risk of exacerbationwith Spiriva® versusthe LABA salmeterol11
* Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF® and in the U.S. under the brand name GILOTRIF® for use in patients with distinct types of EGFR mutation-positive NSCLC. Registration conditions differ internationally, please refer to locally approved prescribing information. Afatinib is under regulatory review by health authorities in other countries worldwide. Afatinib is not approved in other indications.
** Nintedanib is approved in the EU under the brand name VARGATEF® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. Nintedanib is under regulatory review by health authorities in other countries outside the EU. Nintedanib is not approved in other oncology indications.
† Ipratropium bromide/salbutamol is approved under the brand name Combivent® in the US, Canada and Mexico.
¶ Tiotropium is approved in the EU under the brand names Spiriva® HandiHaler® and Spiriva® Respimat® as a maintenance bronchodilator treatment to relieve symptoms of patients with COPD.
§ Respimat® delivers a metered dose of medication in a mist at the push of a button requiring just a slow deep breath from a patient.
× Nintedanib is approved under the brand name OFEV® in the US, EU, Japan and other territories for use in patients with IPF.
± Olodaterol is approved under the brand name Striverdi® Respimat® in the EU and US as a maintenance bronchodilator treatment in patients with COPD.
¢ Tiotropium is approved in the EU under the brand name Spiriva® Respimat® as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800 μg budesonide/day or equivalent) and long-acting β2 agonists and who experienced one or more severe exacerbations in the previous year. Spiriva® Respimat® is approved in Japan for the relief of various symptoms associated with the obstructive impairment of airways due to bronchial asthma (only use for patients with severe persistent asthma).
# Combined figures for HandiHaler® and Respimat®
‡ Tiotropium/olodaterol is approved under the brand name Spiolto® Respimat® in the EU as a once-daily maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Spiolto® Respimat® is registered as Stiolto™ Respimat® in the US.
þ Spiriva® Respimat® is approved by the U.S. Food and Drug Administration (FDA) for the long-term, once-daily, prescription maintenance treatment of asthma in people ages 12 and older. Spiriva® Respimat® is not indicated for the relief of acute bronchospasm.
For further Boehringer Ingelheim media information please visit http://newscentre.boehringer-ingelheim.com/
2014Phase III data showed tiotropium Respimat® in asthma as add-on to at least ICS/LABA maintenance therapy significantly improved asthma symptom control in adults16
2014Approval of Spiriva® Respimat® for use in asthma by regulatory authorities in the EU, Japan and many other countries¢
2012Launch ofCombivent®
Respimat®
(ipratropiumbromide andalbuterol) forthe treatmentof COPD
2015To date, Spiriva® has over 40 million patient-years# ofreal-life experience across all COPD severities
2015Spiolto® Respimat® (tiotropium/ olodaterol) receives first Europeancountry approvalsas a once-daily maintenancetreatment to relievesymptoms in adult patients with COPD‡
2015Approval of Spiriva® Respimat® for use in asthma in the USþ
2015Once-daily Stiolto™Respimat®
(tiotropium/olodaterol)Inhalation Spray isapproved by US FDA as a long-term,once-daily maintenancetreatment of airflowobstruction inpatients with COPD,including chronicbronchitis and/oremphysema
2015OFEV® approvedby the EuropeanCommission forthe treatment of IPF
2015OFEV® included in the Updated International Treatment Guidelines for Idiopathic Pulmonary Fibrosis17
2015Inclusion ofSpiriva® Respimat®
in the updatedGINA 2015 GlobalStrategy for AsthmaManagementand Prevention
References:1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of COPD. 2003. Available from: http://www.goldcopd.org/ 2. Newman SP, Brown J, Steed KP, et al. Lung deposition of fenoterol and flunisolide delivered using a novel device for inhaled medicines: Comparison of Respimat® with conventional metered-dose inhalers with and without spacer devices. Chest 1998; 113: 957-963. 3. Pitcairn G, Reader S, Pavia D, et al. Deposition of corticosteroid aerosol in the human lung by Respimat® Soft Mist™ Inhaler compared to deposition by metered dose inhaler or by Turbuhaler® dry powder inhaler. J Aerosol Med 2005; 18(3): 264-272. 4. Peterson JB, Prisk GK, Darquenne C. Aerosol deposition in the human lung periphery is increased by reduced-density gas breathing. J Aerosol Med Pulm Drug Deliv. 2008; 21(2): 159–168. 5. Dalby R, Spallek M, Voshaar T. A review of the development of Respimat® Soft Mist™ Inhaler. Int J Pharm 2004; 283: 1-9. 6. Zierenberg B. Optimising the in vitro performance of Respimat®. J Aerosol Med 1999; 12 (Suppl 1): S19-S24. 7. Dalby RN, Eicher J, Zierenberg B. Development of Respimat® SoftMist™ inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl) 2011; 4: 145-155. 8. Anderson P. Use of Respimat® Soft Mist Inhaler in COPD patients. Int J COPD 2006;1(3): 251–259. 9. Boehringer Ingelheim. Data on file. 10. Tashkin DP, Celli B, Senn S, et al. On behalf of the UPLIFT® (Understanding Potential Long-term Impacts on Function with Tiotropium) study investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008; 359: 1543-1554. 11. Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011; 364(12): 1093-1103. 12. Wise RA, Anzueto A, Cotton D, et al. Tiotropium Respimat® Inhaler and the Risk of Death in COPD: The Tiospir Trial. N Engl J Med 2013; 369(16): 1491-1501. 13. Ferguson GT, Feldman GJ, Hofbauer P, et al. Efficacy and safety of olodaterol once daily delivered via Respimat® in patients with GOLD 2–4 COPD: results from two replicate 48-week studies. Int J COPD 2014; 9: 629-645. 14. Richeldi L, et al. Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis. N Engl J Med 2014; 370(22):2071-2082. 15. Buhl R, Maltais F, Abrahams R, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD2-4). Eur Respir J 2015; 45(4): 969-979. 16. FitzGerald JM, Kerstjens HAM, Paggiaro P, et al. Once-daily tiotropium Respimat® add-on to ICS±LABA. Thorax 2014; 68(Suppl 2): A49-A50. 17. Raghu G, et al. An Official ATS/ERS/JRS/ALAT Clinical Practice Guidelines: Treatment of Idiopathic Pulmonary Fibrosis: Executive Summary. AJRCCM 2015; 192(2): 238-248.
