Lipella Gets FDA Orphan Designation for LP-310 in Oral Graft-vs-Host Disease

By Colin Kellaher

Lipella Pharmaceuticals on Friday said the U.S. Food and Drug Administration granted orphan-drug designation for LP-310 for the treatment of oral graft-versus-host disease.

The Pittsburgh clinical-stage pharmaceutical company said LP-310 is an oral-rinse formulation of its lead drug candidate, LP-10, which previously won FDA orphan-drug designation.

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.

Oral graft-versus-host disease, which occurs when donor bone marrow or stem cells attack the recipient, causes significant pain and discomfort, making it difficult for patients to eat, drink and speak, Lipella said.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

11-10-23 0843ET