The approval of Spiriva Respimat (tiotropium bromide; Boehringer Ingelheim), a first-in-class long-acting muscarinic antagonist, for the treatment of asthma will see uptake in a small patient subgroup, targeting moderate to severe patients whose asthma symptoms persist despite taking a daily maintenance treatment. While Spiriva will not be as lucrative in the asthma market as it has been in the chronic obstructive pulmonary disease (COPD) market, this expansion will successfully help Boehringer Ingelheim expand its presence in the respiratory drug market.
On 16 September 2015, Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) approved its long-acting muscarinic antagonist (LAMA) Spiriva Respimat for the long-term, once-daily, prescription maintenance treatment of asthma in patients ages 12 and older. The drug, which was first approved in 2014 in the EU as an add-on maintenance treatment in adult patients with asthma, is the first LAMA approved in the US for the treatment of asthma, establishing a new class of asthma medication. Additionally, in the Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention report 2015 update, add-on tiotropium by soft-mist inhaler has been included as a recommended “other controller option” for adults with exacerbations. This update supports the use of Spiriva Respimat and will facilitate its uptake in the asthma market.
Spiriva Respimat is a once-daily, dry powder formulation of anticholinergic with specificity for muscarinic receptors. When inhaled, this formulation achieves smooth muscle relaxation and bronchodilation in the airway. The FDA approval of Spiriva Respimat was based on positive efficacy and safety data from a clinical trial program comprising 12 trials of approximately 5,000 adults and adolescents with mild, moderate and severe symptomatic asthma on at least an inhaled corticosteroid at baseline. Clinical trial results demonstrated that Spiriva Respimat as an add-on therapy to medium-dose inhaled corticosteroids can lead to significant lung function improvement, as measured by forced expiratory volume in one second, and reduced exacerbations for asthma patients, compared to placebo regardless of inflammatory status. An asthma exacerbation was defined as a progressive increase in symptoms or a decrease in a patient’s best morning peak expiratory flow that required treatment with systemic steroids for at least three days. Spiriva’s safety profile was demonstrated across the clinical trial program, with the most common side effects occurring in less than 2% of patients over 12 to 52 weeks. These side effects included sore throat, sinus infections, bronchitis, and headache in adults. Strong efficacy and safety results from these trials will contribute to its uptake on the market. While Spiriva will not be as lucrative in the asthma market as it has been in the COPD market, it will be suitable for use in patients with moderate to severe asthma who remain symptomatic on current therapy. Spiriva will fill an unmet need for these patients, and strong physician familiarity with the drug will support uptake in this population . With Spiriva’s FDA approval for use in asthma, Boehringer Ingelheim is expanding on and protecting its respiratory presence, a strategic move that is vital in the face of increasing competition in the COPD market.