CELLVIE’s mitochondria treatment has been granted orphan-drug designation from the FDA
CELLVIE's mitochondria treatment has been granted orphan drug designation from the FDA
The Orphan Drug Act, a law passed in 1983, provides for granting special status to a drug or biological product to treat a rare disease or condition, with the goal being accelerated evaluation and development of promising medical products. This special orphan drug status comes with multiple benefits:
- Eligibility for market exclusivity for 7 years post approval
- Tax credits of 50% off the clinical drug testing cost awarded upon approval
- FDA fast-track for evaluation & FDA recommendations
Pushing for medical breakthroughs since being founded in 2018, cellvie is leveraging the therapeutic potential of mitochondria to ameliorate society's burden stemming from ischemia-reperfusion injury (IRI). Now, cellvie is proud to announce that it has been granted orphan-drug designation for the use of mitochondria in the prevention of ischemia-reperfusion injury during solid organ transplantation, reaching an important milestone in the development of its therapy's first application. "We are particularly excited about the prospect of accelerating our path to market, to reach the patients in need quickly," said Alexander Schueller, Founder and CEO of cellvie.
About cellvie Inc. Founded in the US and headquartered in Zürich, Switzerland, cellvie is developing medicines from cells, leveraging the therapeutic potential of mitochondria.
The company was founded by Drs. McCully, Schueller, del Nido and Emani in 2018. Dr. McCully pioneered the approach of mitochondria augmentation and replacement at Harvard Medical School and the team has now set out to bring it about as a new treatment modality in ischemia-reperfusion injury, aging, and beyond.
Further information can be found at www.cellvie.bio.