Mereo Gets FDA Orphan Designation for Alvelestat in Alpha-1 Antitrypsin Deficiency

By Colin Kellaher

Mereo BioPharma Group PLC on Tuesday said the U.S. Food and Drug Administration granted orphan-drug designation to alvelestat for the treatment of alpha-1 antitrypsin deficiency, an genetic disorder that could cause lung disease and liver disease.

The London clinical-stage biopharmaceutical company said it developing alvelestat for the treatment of lung disease associated with the disorder, with a Phase 2 proof-of-concept clinical trial underway.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing-exclusivity period against competition.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

October 26, 2021 08:42 ET (12:42 GMT)

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