BioCentury
ARTICLE | Clinical News

Hemlibra patient develops neutralizing anti-drug antibodies

April 27, 2018 7:40 PM UTC

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) disclosed that a hemophilia A patient who was receiving Hemlibra emicizumab-kxwh in the Phase III HAVEN 2 trial developed neutralizing anti-drug antibodies to Hemlibra that resulted in reduced efficacy of the drug. The patient subsequently discontinued treatment with Hemlibra and resumed his prior treatment. Genentech said the patient is the “the first confirmed report of a detectable anti-drug antibody that has impacted the efficacy of Hemlibra" in more than 600 hemophilia A patients treated with the drug worldwide, including clinical trials.

The open-label, international HAVEN 2 trial enrolled about 88 pediatric hemophilia A patients with Factor VIII inhibitors (see BioCentury, July 7, 2017)...