Teva Pharmaceutical Industries Ltd has simultaneously launched the AirDuo RespiClick (fluticasone propionate and salmeterol) inhalation powder and its authorized generic for the treatment of asthma.
The devices are indicated for patients aged 12 years and older who are uncontrolled on an inhaled corticosteroid (ICS) or whose disease severity clearly warrants the use of an ICS/LABA combination, according to Teva. The products are not indicated for the relief of acute bronchospasm, the company noted.
AirDuo RespiClick and its authorized generic are fixed-dose combination asthma therapies containing an ICS and a LABA, the same active ingredients as Advair. Teva said it expects that sales of the authorized generic will represent most of the sales of the two products.
Reuters is reporting that the products will compete with GlaxoSmithKline’s Advair for asthma. “[It] will be the first direct competition to GlaxoSmithKline’s best-selling Advair. … AirDuo is not a true generic of Advair, but contains the same two active ingredients, fluticasone propionate and salmeterol. However, it delivers a lower dose of salmeterol and uses Teva’s RespiClick inhaler rather than copying GSK’s device,” according to a Reuters report.
AirDuo RespiClick was approved by the US FDA in January 2017 in three doses: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily.
“With the launch of AirDuo RespiClick and its authorized generic, our intent is to meet the needs of patients, providers, and payers in the U.S. seeking greater access to lower-cost asthma inhaler technology, while also allowing Teva to compete in the highly competitive asthma combination controller market,” said Rob Koremans, M.D., President and CEO of Global Specialty Medicines at Teva. “This important launch marks not only the first available generic ICS/LABA product in the U.S., but also the continued expansion of our RespiClick family of products, which now includes breath-activated inhaler options for both maintenance treatment and rescue medication.”
More info, including the products’ safety information, is available at the Teva website.