Asthma: Boehringer Ingelheim announces U.S. FDA filing acceptance of NDA for Spiriva® Respimat® in asthma

For media outside the US, the UK & Canada only

  • Data show Spiriva (tiotropium) Respimat as an add-on therapy improves symptoms and reduces risk of severe asthma exacerbations1,2
  • Almost one in two patients with asthma still experience symptoms while receiving current treatment options3,4,5
  • The indication for Spiriva Respimat in asthma has been approved in the EU

Ingelheim, Germany, 04 November, 2014 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for Spiriva (tiotropium) Respimat for the long-term, once-daily, add-on maintenance treatment of asthma in patients 12 years of age and older who remain symptomatic on at least inhaled corticosteroids (ICS). Spiriva Respimat has already been approved for the treatment of asthma in adults in the EU.

Professor Klaus Dugi, Chief Medical Officer
Professor Klaus Dugi,
Chief Medical Officer

"We know that patients who experience asthma symptoms have about a six times greater chance of having a potentially life-threatening asthma attack over the next few weeks than those with minimal-to-no daytime symptoms.6There is a critical need for a new treatment option to provide benefits to, and improve outcomes for, patients with asthma. The FDA’s acceptance of our application brings us a step closer to providing a potential new treatment option for use as an add-on to maintenance treatment," said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.

To read the press release announcing the acceptance of Spiriva Respimat in asthma in the EU, please click here.

For more information on Spiriva Respimat and asthma, please view the infographic here.

For more information on the U.S. FDA filing acceptance of Spiriva Respimat in asthma, see the respective U.S. press release here.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.

For more information please visit www.boehringer-ingelheim.com

Footnotes

*defined as a deterioration of asthma symptoms that requires initiation or at least a doubling of systemic glucocorticoids for ≥3 days
†Tiotropium Respimat® for use in asthma is currently being reviewed by regulatory authorities; it is approved as Spiriva® Respimat® for use in asthma in the EU, Chile, Colombia, Ecuador, Mexico, Russia, Thailand and The Phillipines. Spiriva® Respimat® is indicated 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 **according to the EU decentralised procedure

Referências

  1. Fitzgerald JM, Kerstjens HAM, Paggiaro P, et al.  Once daily tiotropium Respimat add-on to ICS±LABA improves control across asthma severities.  ERS 2014 Abstract No. 1894
  2. Kerstjens HAM, Engel M, Dahl R et al. Tiotropium in asthma poorly controlled with standard combination therapy. N Engl J Med 2012; 367 (13): 1198-1207
  3. Bateman ED, Boushey HA, Bousquet J, et al. GOAL Investigators Group. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004; 170 (8): 836-44
  4. Partridge MR, Dal Negro RW, Olivieri D, et al. Understanding patients with asthma and COPD: insights from a European study. Prim Care Respir J 2011; 20 (3): 315-323
  5. Demoly P, Paggiaro P, Plaza V, et al. Prevalence of asthma control among adults in France, Germany, Italy, Spain and the UK. Eur Respir Rev 2009; 18: (112): 105–112
  6. Bateman ED, Reddel HK, Eriksson G, et al. Overall asthma control: the relationship between current control and future risk. J Allergy Clin Immunol. 2010; 125(3): 600-8