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FDA Updates: Orladeyo in Hereditary Angioedema; Priority Review for Pfizer Pneumococcal Vaccine


Pfizer's other vaccine news of the week involves pneumococcal disease.

Orladeyo to prevent attacks in hereditary condition. On December 3, 2020, BioCryst Pharmaceuticals announced that FDA had approved Orladeyo(berotralstat), an oral, once-daily treatment to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. HAE is a rare genetic condition that causes repeated attacks of subcutaneous or submucosal edema that affecting the face, respiratory tract, extremities, gastrointestinal tract, or other areas. It can be difficult to diagnose because the symptoms resemble allergic reactions. Orladeyo was safe and well tolerated, with the most common side effects being gastrointestinal reactions; these typically resolved after treatment initiation.

Priority review for BLA in pneumococcal conjugate vaccine. COVID-19 wasn’t the only area where Pfizer made vaccine news last week. On Tuesday, the FDA accepted for priority review a Biologics License Application (BLA) for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, which would prevent invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine. The submission seeks approval for adults ages 18 years and older. The vaccine candidate includes capsular polysaccharide conjugates for the 13 serotypes already included in Pfizer’s Prevnar 13 vaccine. The 20 serotypes included in the 20vPnC are responsible for most cases of pneumococcal disease in the United States and worldwide. A target approval date will be set for June 2021.

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