Final reports from Precigen showed long-term effectiveness of the injections with reduced side effects.
The Food and Drug Administration (FDA) has approved a drug manufactured by Precigen to treat adults with recurrent respiratory papillomatosis (RRP). After reviewing the studies released by the biomedical company, the agency found that 12-24 months of dosing the immunotherapy drug achieved a complete response to the ailment with no surgeries and no adverse side effects greater than grade 2.
“Randomized trials are not always needed to approve medical products, and this approval is proof of that philosophy,” said Director Vinay Prasad of the FDA’s Center for Biologics Evaluation and Research (CBER). “The FDA will always demand the correct clinical study for the specific medical product and disease.”
“For more than a century, since RRP was first recognized as a distinct disease, patients have had to rely on repeated surgeries to manage this relentless condition,” Precigen President and CEO Helen Sabzevari stated. “With the landmark FDA approval of Papzimeos and broad label, all adult RRP patients are now eligible for access to the first and only approved therapy that targets the root cause of the disease.”
As the Lord Leads, Pray with Us…
- For Director Prasad to be prudent as he heads the Center for Biologics Evaluation and Research.
- For wisdom for FDA Commissioner Makary as he oversees the approval and authorization of new medications and therapies.
Sources: UPI News, Food and Drug Administration
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