The first drug for the treatment of respiratory papillomatosis has been approved

The first immunotherapy for recurrent respiratory papillomatosis in adults has been approved by the US Food and Drug Administration (FDA). 

Precigen's Papzimeos is the first drug for such a rare disease to be approved in Phase I/II clinical trials .

38 volunteers participated in the clinical trials, of which 35 participants were given a high dosage of immunotherapy, which proved effective. After this therapy, 51% of the trial participants had tumors completely disappeared, and the majority (83%) of the patients did not require surgery for two years, while the rest did not require surgery for a year.

Papzimeos is a drug that trains the immune system to recognize and attack human papillomavirus (HPV) infected cells by delivering a therapeutic substance to them in the composition of an adenovirus incapable of reproduction.

The drug is administered four times subcutaneously for 12 weeks after surgery.

Papillomatosis is an extremely rare disease, where for every 100,000 people there are from 1 to 9 cases annually. The disease occurs due to the prolonged presence of HPV type 6 or type 11 in the body. At the same time, there is an increase in benign neoplasms (papillomas) in the respiratory organs, most often in the larynx, which is why such patients usually have hoarseness and breathing problems. 

Before the advent of Papzimeos, this pathology could only be treated surgically.