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Bioequivalence of canakinumab liquid pre-filled syringe and reconstituted lyophilized formulations following 150 mg subcutaneous administration: a randomized study in healthy subjects.

Author(s): Chioato A(1), Noseda E, Colin L, Matott R, Skerjanec A, Dietz AJ.

Affiliation(s): Author information: (1)Novartis Institutes for BioMedical Research, Translational Medicine, 4002, Basel, Switzerland, andrea.chioato@novartis.com.

Publication date & source: 2013, Clin Drug Investig. , 33(11):801-8

BACKGROUND: Canakinumab is a human anti-interleukin-1beta antibody approved for the treatment of cryopyrin associated periodic syndrome currently formulated as a lyophilized powder requiring reconstitution. A new formulation (solution for injection as pre-filled syringe) has been developed to avoid reconstitution. OBJECTIVE: The objective of this study was to evaluate the bioequivalence of pre-filled syringe and reconstituted formulations following 150 mg administration in healthy subjects. METHODS: This was an open-labeled, randomized, single dose, parallel-group study in 130 healthy subjects, followed for 120 days. Subjects received a single subcutaneous injection of 150 mg canakinumab after either reconstitution or in pre-filled syringe formulation, followed by pharmacokinetics/pharmacodynamics evaluations and safety assessments. The main outcome measure for the study was the pharmacokinetic bioequivalence of the two formulations, which was concluded if the 90% confidence intervals for the ratios of AUC(last) (area under the serum concentration-time curve from time zero to time of last measurable concentration) and C(max) (maximum serum concentration) were entirely contained within the interval, 0.80-1.25. RESULTS: The arithmetic mean values for the exposure parameters C(max) and AUC(last) were similar for the two formulations. The geometric mean ratio (pre-filled syringe vs. lyophilized form) of C(max) and AUC(last) were 0.99 and 1.01. The associated 90% confidence intervals were 0.90 to 1.08 and 0.94 to 1.09, respectively. Most common adverse events were headache and nasopharyngitis. Neutropenia occurred in 2 cases (reported as serious adverse events). No deaths occurred. CONCLUSION: The 150 mg liquid pre-filled syringe and lyophilized formulations of canakinumab are bioequivalent.

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