AZ's Breztri scored in the COPD trial, adding a place to GSK's triple-combined battle

AstraZeneta and GlaxoSmithKline, which have a clear advantage in the three-drug inhaler market, have long been deadlocked in their battle for respiratory advantage. Can positive data from another round of combined inhalers help AstraZeneta?
AstraZenega's three-drug copd med breztri gas ring significantly reduced the rate of deterioration in patients with chronic obstructive pulmonary disease than its own two-drug treatment, according to phase III psychiatric trial data released Wednesday. Also Wednesday, the U.S. Food and Drug Administration gave Azkaban's Fassenra the status of an orphan drug for the treatment of eosinophilic esophagealitis, a very rare disease that has not yet been approved by the U.S. Food and Drug Administration, the drugmaker said. In addition to patent protection, the name has seven years of exclusive rights and other benefits.
Overall, progress in AstraZeneca's respiratory portfolio highlights the escalation of the battle between British drugmakers and the country's GlaxoSmithKline for the advantage in this area - particularly in the triple-throes.
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AstraZeneca's chronic obstructive pulmonary disease triad Brestry, competing with GlaxoSmithKline's Tracy, has won Japan's approval Breztri is currently approved in Japan to treat chronic obstructive pulmonary disease, but is not approved in the United States and faces fierce competition from GlaxoSmithKline's Trelegy Ellipta, which has a clear lead in the three-drug inhaler category. But Wednesday's data could bring some advantages: Both doses of Breztri beat the combination of the two drugs, which, as trial researchers point out, gives doctors more flexibility in prescribing.
Triple inhalers have been reviewed by the FDA and the European Medicines Agency, but Mene Pangalos, AstraZeneta's executive vice president of biopharmaceutical research and development, said the company looked forward to passing on the new data to regulators as soon as possible.
The new data reinforces the third phase of Kronos, released in September, which showed that Brizetri Bitaz's Sebankt and two other drug inhalers improved the amount of force exhalation (FEV1) per second at almost every point in the 24-week period -- measuring breathing capacity.
At the time, Breztri was deficient in the same metrics as the dual drug Bevespi, but AstraZeneta noted that Breztri did post a numericly favorable trend, but not strong enough to exceed statistically significant thresholds.
Now, with Japan's approval and european and regulatory reviews under way, AstraZeneca is hoping to take a share of Trelegy's market-leading second-quarter sales of 120 million pounds.
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analysis: AstraZeneta's
Fasenra
offers two-year benefits to people with severe asthma Meanwhile, AstraZeneta can rest assured that it will use other breathing drugs to boost GlaxoSmithKline while waiting for the triple-combination to catch up. Example: Fasenra reached $296 million in the first half of 2019 - up 244 percent from last year.
AstraZenech boasts that although Fasenra is the third product to be marketed for eosinophilic asthma, it has become the biological agent of choice for new surgical patients.
Fasenra is fighting a familiar enemy, GSK's Nucala, as well as Teva's Cinqair and Novartis' Xolair, and GSK's Nucala has not yet been approved for the treatment of acidic granulocytic asthma. Nucala has been trying to keep up with Fassella's easier dosing program, and for Nucara, two new dosing devices approved by the U.S. Food and Drug Administration in June -- a self-administration auto-injector and a pre-charged syringe -- could pose a challenge to Az's drug.AstraZeneta's breathing franchise grew 5 per cent in the first half of the year, with sales of $2.5bn, following Fasenra's rise. （cyy123.com）