WAYNE, PA
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Palvella Therapeutics, Inc.
(Nasdaq: PVLA) has been awarded its fifth U.S. patent for QTORIN™ 3.9% rapamycin anhydrous gel, strengthening its role in developing therapies for uncommon dermatological conditions. This recently issued patent number 12,268,673 prolongs the patent coverage for QTORIN™ rapamycin until 2038 and includes claims related to its formulation as well as usage methods, particularly addressing applications for microcystic lymphatic malformations (microcystic LMs).
QTORIN™ rapamycin has the possibility of becoming the initial FDA-approved therapy for microcystic LMs, an intense and disabling genetic disorder impacting more than 30,000 individuals in the U.S. This ailment involves faulty lymphatic vessels that leak and bleed frequently, leading to repeated infections and severe issues. At present, no treatments have been authorized for this illness.
This latest U.S. patent, being the fifth one, underscores the substantial innovation involved in the creation of QTORIN™ rapamycin and Palvella’s QTORIN™ technology,” stated Wes Kaupinen, who is both the Founder and CEO at Palvella Therapeutics. “We are delighted to enhance our expanding intellectual property collection as we continue working toward developing the premier targeted treatment for microcystic lymphatic malformations.
The gel has already been granted Breakthrough Therapy, Orphan Drug, and Fast Track designations by the FDA, indicating its potential to address an important unmet medical need. Should it receive approval, it would also qualify for seven years of market exclusivity pursuant to its Orphan Drug status.
Palvella’s ongoing progress in developing treatments for rare diseases highlights their dedication to serving marginalized patient groups, providing encouragement for individuals who previously had limited therapeutic choices.