Alpha Therapeutics holding four lots of AlphaNine SD coagulation Factor IX for HAV safety review.

Executive Summary

ALPHA THERAPEUTICS CONDUCTING HEPATITIS A REVIEW OF ALPHANINE SD coagulation Factor IX (human) lots CA5410A, CA5412A, CA5413A and CA5421A and advises distributors in a Jan. 12 letter that "these lots are on hold pending the confirmation of their safety." FDA says the four lots of Factor IX were produced using plasma pools common to Alphanate Factor VIII lot AP5014A, which was voluntarily withdrawn from the market Dec. 8 due to three suspected hepatitis A virus transmissions. Two of the transmissions were definitively linked to the plasma product by polymerase chain reaction testing completed by the Centers for Disease Control & Prevention Jan. 12.