Building 1 at the FDA’s White Oak campus in Silver Spring, Maryland, in May 2009. Archive photo.
Photo: U.S. Food and Drug Administration / Wikimedia Commons. Public domain. Cropped.
The FDA on Friday granted accelerated approval to a new treatment designed to reduce repeated surgeries for adults with a rare disease that causes wart-like growths in their airways, marking the first U.S. approval of a plasmid DNA-based immunotherapy.
The treatment, Inovio Pharmaceuticals’ Voceryq, targets human papillomavirus types 6 and 11, which cause recurrent respiratory papillomatosis. The growths often form around the voice box and vocal cords, causing hoarseness, coughing and voice changes. Severe cases can make breathing difficult.
Surgery can remove the growths, but the virus can remain in tissue and patients may need procedures repeatedly over many years, the FDA said in its October 30 announcement. The approval is not a claim that the disease has been cured.
The evidence comes from a small, open-label, multicenter trial involving 32 adults who had undergone at least two surgeries in the previous year. In the 26-patient efficacy group, whose members had needed at least three surgeries before treatment, seven patients, or 27%, required no surgery during the first year after treatment.
The accelerated approval rests on reduced need for surgery, an intermediate clinical outcome that the FDA considers reasonably likely to predict clinical benefit. Inovio must conduct post-approval studies to verify and describe that benefit. Continued approval may depend on those findings.
Voceryq delivers two small pieces of DNA into cells: one carries instructions for HPV proteins, while the other carries instructions for IL-12, a molecule that enhances the immune response. It is designed to train the immune system to attack cells infected by the relevant HPV types.
The medicine is given by an injection into muscle using Inovio’s Cellectra 5PSP device, which applies brief electrical pulses to help the DNA enter cells. Commonly reported reactions included injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness. The electrical-pulse procedure can also cause temporary muscle contractions, bleeding, pain and lightheadedness.
Inovio said Friday it expects the medicine to be available to order and ship in about 60 days, with a full commercial launch in the first quarter of 2027. Those are company forecasts, not confirmation that the treatment is available for immediate use.
JBizNews Desk | Health Policy
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