U.S. FDA grants orphan drug status to AstraZeneca's asthma drug Fasenra

[August 28, 2019]  (Reuters) - AstraZeneca said on Wednesday that the U.S. Food and Drug Administration granted orphan drug status for its drug to treat eosinophilic esophagitis and unveiled positive results from a late-stage trial on a triple-drug therapy targeting a severe lung disease.

Fasenra would treat allergic oesophagitis, an allergic inflammatory disease of the esophagus. The health regulator grants orphan status to drugs that are intended to treat and prevent rare diseases or disorders that affect fewer than 200,000 people in the U.S.

Separately, AstraZeneca said it met the main goal for its late-stage ETHOS trial for triple-drug therapy Breztri Aerosphere, formerly known as PT010, to treat moderate to very severe chronic obstructive pulmonary disease (COPD), a condition that limits airflow to the lungs.

"The Phase III ETHOS trial results are exciting and demonstrate that Breztri Aerosphere significantly reduces the rate of exacerbations," said Klaus Rabe, the lead investigator of the ETHOS trial.

Breztri Aerosphere demonstrated a significant reduction in the rate of moderate or severe worsening of the condition compared with company's dual-drug COPD therapies Bevespi Aerosphere and PT009, the company said.

(Reporting by Justin George Varghese in Bengaluru; Editing by Bernard Orr)

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