- Novartis ( NYSE: NVS ) completed a filing to the U.S. FDA seeking approval of a Millburn, N.J.-based radioligand therapy manufacturing facility for commercial production of prostate cancer drug Pluvicto for U.S. patients.
- The Swiss pharma giant added that it has requested an expedited review from the agency and pending approval, Millburn could begin supplying Pluvicto by this summer, expanding its current manufacturing capacity.
- Novartis is also building a new facility in Indianapolis which could be operational by the end of 2023. The site will add significant commercial supply of Pluvicto for U.S. patients, according to the company.
- With these facilities, Novartis aims to produce at least 250K doses of Pluvicto annually in 2024.
For further details see:
Novartis files for FDA approval of radioligand facility to ramp up production of Pluvicto