The Food and Drug Administration on Aug. 14 approved a therapy for a rare disease called recurrent respiratory papillomatosis (RRP).
Regulators cleared Papzimeos, an immunotherapy made by Precigen, citing data from a single-arm, open-label trial that looked at how it performed in adults with RRP and who needed at least three surgeries a year.
Patients received four injections of the therapy over 12 weeks following surgical procedures.
About half of the participants needed no surgery in the year following treatment. The safety profile was also deemed favorable.
“Randomized trials are not always needed to approve medical products and this approval is proof of that philosophy,” Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement….