Palvella Completes Rolling NDA For QTORIN Rapamycin In Microcystic Lymphatic Malformatios

India, Aug. 31 -- Palvella Therapeutics, Inc. (PVLA) announced that it has completed the rolling submission of its NDA to the U.S. FDA for QTORIN 3.9% rapamycin anhydrous gel.

The therapy is being developed for microcystic lymphatic malformations (microcystic LMs), a rare and chronically debilitating genetic disease with no FDA-approved treatment.

Microcystic LMs affect an estimated 30,000 pediatric and adults patients in the U.S., often causing lifelong complications. QTORIN rapamycin has previously received Breakthrough Therapy, Fast Track, and Orphan Drug designations, underscoring its potential to address a significant unmet medical need.

The NDA submission includes results from the Phase 3 SELVA trial, which met its primary endpoint...