FDA approves radiopharmaceutical manufacturing site in Indianapolis
Novartis announced the opening of a new 70,000-square-foot facility for the manufacturing of radiopharmaceutical Pluvicto (177Lu-vipivotide tetraxetan). The U.S. Food and Drug Administration (FDA) has approved the move, with Novartis calling the radioligand therapy site its “largest and most advanced facility of its kind."
Pluvicto is a crucial prostate-specific membrane antigen-targeted nuclear medicine therapy for prostate cancer, and it plays a pivotal role in treating individuals in the advanced stages of the disease. According to the Society of Nuclear Medicine & Molecular Imaging (SNMMI), challenges in the supply chain of the drug resulted in significant delays in patient care in spring 2023, extending beyond three months. The FDA didn’t officially declare the drug shortage resolved until October.
“Over the course of this past year, we have significantly increased our supply and recently shared that the FDA had classified the drug shortage status of Pluvicto as resolved,” the statement signed by multiple Novartis executives reads. “Having doubled weekly production, we have more than sufficient supply to treat patients within two weeks of diagnosis. We know this is important for your patients with advanced disease in need of treatment quickly”
In its own statement, the SNMMI applauded the FDA approval, citing the “rapidly growing demand for the therapy and past challenges with supply”.
Novartis said Indianapolis makes an ideal location from its facility, as it is centrally located within a 12-hour drive of half the country, which the company noted will improve “access for patients and treatment centers” and hopefully mitigate future shortages.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.