The Food and Drug Administration has turned down a new drug from AstraZeneca for treating chronic obstructive pulmonary disease despite its being approved elsewhere.
The London-based drugmaker said Tuesday that the FDA had issued a complete response letter for PT010 (budesonide, glycopyrronium, formoterol fumarate), an inhaled therapy for COPD. The drug was nevertheless approved in Japan in June, under the brand name Breztri Aerosphere, and is under regulatory review in the European Union as well as in China, where the National Medical Products Administration has given it priority review.
Shares of AstraZeneca were down 1.8 percent on the New York Stock Exchange Tuesday.
AstraZeneca’s regulatory submission was based on data from the Phase III KRONOS trial, one of the four key studies in its broader Phase III ATHENA program. The company did not say what specific problems led the FDA to issue the complete response letter. However, it stated that it would work with the agency and submit data from another study from the program, ETHOS, results of which were released in late August.
In an email, a company spokesperson noted that ETHOS was not yet complete by the time AstraZeneca submitted for approval, and data from the study are important to further characterize PT010’s clinical profile. A decision by the FDA is expected in 2020.
The rejection means that for the time being, fellow British drugmaker GlaxoSmithKline’s Trelegy Ellipta (fluticasone furoate, umeclidinium, vilanterol) is the only COPD drug that combines three active ingredients currently available in the U.S., having won FDA approval in 2017. Trelegy Ellipta had sales of 156 million pounds, or $192 million, in 2018, according to GSK.
According to the ETHOS results, announced on Aug. 28, PT010 showed a statistically significant reduction in the rate of moderate or severe exacerbations of COPD compared with the two-drug therapies Bevespi Aerosphere (glycopyrronium, formoterol fumarate) and PT009 (budesonide, formoterol fumarate), whether given in the version with 320 micrograms of budesonide or with 160 micrograms.
Top-line results of the KRONOS study were announced in January 2018. That trial compared PT010 with Bevespi Aerosphere, PT009 and the Symbicort Turbuhaler (budesonide, formoterol fumarate), which contains higher dosages of its active ingredients than PT009. That study met eight of its nine primary endpoints. The other two trials in the ATHENA program are TELOS and SOPHOS. COPD is estimated to affect
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