- Palvella Therapeutics (PVLA, Financial) secures its fifth U.S. patent for QTORIN™ rapamycin, extending protection until 2038.
- QTORIN™ rapamycin receives Breakthrough Therapy, Orphan Drug, and Fast Track FDA designations.
- Potential for seven years of orphan drug market exclusivity upon FDA approval.
Palvella Therapeutics, Inc. (PVLA), a clinical-stage biopharmaceutical company, has been awarded its fifth U.S. patent (No. 12,268,673) for QTORIN™ rapamycin, extending the patent protection until 2038. This newly granted patent broadens the protection for QTORIN™ 3.9% rapamycin anhydrous gel, enhancing its intellectual property portfolio targeted at microcystic lymphatic malformations (LMs) and other rare skin diseases.
QTORIN™ rapamycin has secured multiple designations from the U.S. Food and Drug Administration (FDA), including Breakthrough Therapy, Orphan Drug, and Fast Track, specifically for the treatment of microcystic LMs. These regulatory recognitions are critical as they enhance the potential for faster development and review processes, offering expedited access to patients upon successful clinical outcomes.
If ultimately approved by the FDA, QTORIN™ rapamycin would mark a significant milestone as the first approved therapy for microcystic LMs. The therapy would also benefit from seven years of market exclusivity in the U.S. under the orphan drug designation, granting Palvella a competitive advantage in this niche market.
Microcystic lymphatic malformations are a rare, genetic skin disease characterized by malformed lymphatic vessels. With over 30,000 diagnosed cases in the United States and no current FDA-approved treatments, QTORIN™ rapamycin has the potential to fill a significant unmet medical need and establish a standard of care for this debilitating condition.
Palvella's strategy in securing this patent and regulatory designations underlines its commitment to addressing rare genetic diseases. The extended patent protection provides assurance for continued development while potentially cementing Palvella’s position as a leader in this specialized therapeutic area.
