FDA Approves Copies of Advair and Flovent for Asthma Patients

Fully substitutable generics await approval

The FDA has given the nod to two new products for adolescents and adults with asthma, according to a report from BusinessWire. These products, AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) and ArmonAir RespiClick (fluticasone propionate inhalation powder), include medication delivered via the RespiClick breath-activated, multidose dry-powder inhaler. The two products were developed by Teva Pharmaceuticals.

The FDA’s approval of AirDuo RespiClick and ArmonAir RespiClick was supported by data from Teva’s clinical development program, including three phase 3 trials that evaluated the efficacy and safety of the two treatments in adolescent and adult patients with asthma. In two double-blind studies, both therapies showed greater benefit compared with placebo in the improvement of lung function after 12 weeks of treatment, as measured by the forced expiratory volume in one second (FEV1).

In clinical studies of AirDuo RespiClick, the most common adverse events included nasopharyngitis, headache, cough, oral candidiasis, and back pain. In clinical studies of ArmonAir RespiClick, the most common adverse events included nasopharyngitis, headache, cough, oral candidiasis, and upper respiratory tract infection.

AirDuo RespiClick is a fixed-dose combination product containing the same active ingredients as Advair (GlaxoSmithKline)––fluticasone propionate (a corticosteroid) and salmeterol (a long-acting beta2-adrenergic agonist [LABA])––but it delivers a lower dose of salmeterol. It also uses Teva’s Respiclick inhaler rather than a copy of GSK’s device. AirDuo RespiClick is indicated for the treatment of asthma in patients 12 years of age and older.

ArmonAir RespiClick is an inhaled corticosteroid containing the same active ingredient as Flovent (GlaxoSmithKline)––fluticasone propionate––and is indicated for maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.

Producing cut-price copies of Advair is a major opportunity for generics companies at a time when fewer blockbuster medications are losing patent protection, according to a Reuters report.

For GSK, it is a challenge since Advair has sold more than $1 billion annually since 2001. Global Advair sales were $5.6 billion in 2015, with half of that generated in the United States.

Teva’s products aim to grab some of this asthma business, but the bigger threat will come from fully substitutable generic copies of Advair, which are still pending approval, Reuters reported.

Sources: BusinessWire; January 30, 2017; and Reuters; January 30, 2017.