Novartis used one of its priority review vouchers (PRV) to speed the September approval of Kisqali in early breast cancer, the FDA said Monday.
The FDA did not disclose where this PRV came to Novartis from, but the Swiss biotech has publicly disclosed an industry-leading seven PRVs, three of which were acquired on the open market for between $21 million and $130 million each.
The use of a PRV sped up the supplemental approval by about four months. Novartis noted that this latest nod for Kisqali roughly doubles the treatable adjuvant population and includes patients whose cancer has not yet spread to their lymph nodes. Novartis did not immediately respond to a request for comment.
The FDA on Monday also said it awarded two other PRVs for the approvals of two drugs to treat the rare condition Niemann-Pick disease type C. Those PRVs went to IntraBio’s Aqneursa and Zevra Therapeutics’ Miplyffa, both of which won approval late last month.
The flurry of activity around the rare pediatric PRV program comes as Congress has only passed a short-term reauthorization of the program, running up to Dec. 20. The program still needs to be reauthorized for a longer extension or else it will sunset.
The House in late September unanimously passed a wide-ranging bill via voice vote that will reauthorize the rare pediatric PRV program through 2029. To get it across the finish line, however, the Senate and the Biden administration will have to act in the so-called “lame-duck” period, which will occur after the election and before the next incoming administration takes over.
The FDA, meanwhile, told industry recently that if it’s unable to grant a request for a rare pediatric disease designation by Dec. 20, “a marketing application for that drug cannot be eligible for a voucher under the current provisions of the law.”