Jun 042017

The FDA has expanded the indication for tiotropium (Spiriva Respimat) to include children age 6 and older, based on efficacy data similar to that in adults.

Tiotropium (Spiriva Respimat) was approved by FDA in 2015 for adults with asthma after clinical trials showed benefit of Spiriva as an add-on therapy to patients with persistent asthma symptoms despite use of inhaled corticosteroids with or without long-acting beta-agonists in combination.

Tiotropium's new asthma indication creates an interesting dilemma for physicians treating children with asthma, and to a lesser extent adults.

The clinical trials showing tiotropium's benefit in asthma -- in adults and in children -- were as an add-on treatment to inhaled steroids. To PulmCCM's knowledge, tiotropium has not been tested head to head against inhaled corticosteroids for asthma.

However, Spiriva's FDA indication is not limited to second-line or adjunctive treatment for asthma. Nothing in tiotropium's FDA approval discourages physicians from prescribing it as first-line therapy for asthma.

That will be a tempting proposition for pediatricians and parents who want to avoid any potential growth reduction from long-term use of inhaled steroids in children. Adults who express fear of risks of steroid toxicity may also end up receiving Spiriva in this off-guideline fashion.

The marketing materials for Spiriva have already been updated to emphasize this selling point, referring to the product as a "steroid-free mist." Nothing on Spiriva's landing page mentions that expert guidelines do not (yet) endorse it as a first line therapy for asthma.

The benefits of tiotropium as monotherapy for asthma are as yet unknown. Inhaled corticosteroids have a far longer track record and body of data for efficacy, and are considered first-line controller therapy for asthma in adults and children.

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FDA approves Spiriva (tiotropium) for kids age 6+ with asthma