FDA: Novartis used PRV to expedite Kisqali's new indication

Novartis took advantage of one of its priority review vouchers (PRV) to expedite the approval process for Kisqali in early breast cancer, the FDA announced on Monday. The FDA did not specify the origin of this PRV, but Novartis, a Swiss biotech company, has disclosed that it holds seven PRVs, which is the highest number in the industry. Out of these, three were purchased on the open market for amounts ranging between $21 million and $130 million each.

The utilization of the PRV accelerated the supplemental approval by approximately four months. Novartis highlighted that this recent approval for Kisqali significantly increases the number of patients eligible for treatment. It now also includes those whose cancer has not yet metastasized to their lymph nodes. Novartis did not provide an immediate response to requests for further comments.

Additionally, the FDA announced the granting of two more PRVs for the approvals of drugs aimed at treating Niemann-Pick disease type C. These PRVs were awarded to IntraBio’s Aqneursa and Zevra Therapeutics’ Miplyffa, both of which received approval towards the end of the previous month.

This surge in PRV activity within the rare pediatric PRV program is occurring as Congress has only managed to pass a temporary reauthorization of the program, extending it until December 20. A longer-term reauthorization is still required, otherwise, the program will expire.

In late September, the House of Representatives unanimously passed a comprehensive bill through a voice vote to extend the rare pediatric PRV program until 2029. For this extension to become effective, the Senate and the Biden administration must take action during the "lame-duck" period, which happens after the election and before the new administration takes office.

The FDA has recently informed the industry that if it is unable to grant a request for a rare pediatric disease designation by December 20, the corresponding drug's marketing application will not be eligible for a voucher under the current legal provisions.