Health · Pharma & Biotech · 2 hrs ago
FDA approves first DNA medicine for a rare airway disease
The FDA has approved Inovio’s DNA-based treatment for recurrent respiratory papillomatosis, a rare disease, in the United States.
The disease is linked to HPV and causes growths in the throat and airway that can return after surgery and may obstruct breathing or damage the vocal cords.
VOCERYQ uses DNA to train immune cells to attack infected cells, with an injection followed by electrical stimulation to help DNA enter cells.
In a study of 26 adults, seven went a year without surgery, and 81% of the full study group had fewer operations.
The approval makes VOCERYQ the first DNA medicine approved by the US FDA, but its results appear weaker than those of another approved treatment, though the trials cannot be directly compared.
The approval is conditional because it relies on a small study without a control group, and the FDA could withdraw it if a larger confirmatory trial does not show the treatment works.
Patients must receive four treatments over nine weeks, and further testing will determine whether approval stands.
The US Food and Drug Administration approved Inovio’s VOCERYQ as the first DNA medicine approved by the agency.
The treatment is for recurrent respiratory papillomatosis, a rare disease that causes growths in the larynx and airways.
The FDA granted accelerated approval based on a small trial of 32 adults.
In the trial, 81% of patients had fewer surgeries, while 27% of the 26 analyzed patients needed no surgery during the following year.
The approval may be withdrawn if a confirmatory trial fails to show the treatment works.
- Who
- Inovio, a US biotechnology company, developed VOCERYQ.
- What
- The FDA granted accelerated approval to VOCERYQ, a DNA-based treatment for recurrent respiratory papillomatosis.
- When
- The FDA approved it on October 30, according to the article published November 3, 2026.
- Where
- The approval was granted in the United States.
- Why
- The treatment is intended for a rare disease caused by HPV types 6 and 11, for which the article says surgery had been the main treatment.
This story does not have two clearly opposing sides.
Researchers confirmed that DNA injected into animal muscle could lead to protein production.
India urgently approved a DNA vaccine for COVID-19, according to the article.
The FDA first approved Fregen’s Popziemeos for recurrent respiratory papillomatosis.
Helixmith’s Enzenges received approval in China for severe limb ischemia through its partner Northland Biotech.
The FDA granted accelerated approval to Inovio’s VOCERYQ.
- Drug
- VOCERYQ, also known as INO-3107
- Company
- Inovio
- Disease
- Recurrent respiratory papillomatosis
- Trial
- 32 adults in a phase 1/2 study
- No surgery
- 7 of 26 analyzed patients, or 27%, needed no surgery for one year
- Fewer surgeries
- 81% of patients had fewer surgeries
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