Sanofi’s Lyxumia meets primary endpoint in Ph IIIb diabetes study

Results of a 24-week Phase IIIb clinical study showed that French drug major Sanofi’s (Euronext: SAN) diabetes drug Lyxumia (lixisenatide) met the primary endpoint of non-inferiority in blood sugar lowering (HbA1c) when administered either before breakfast or the main meal of the day. These results indicate that lixisenatide can effectively lower blood sugar at either time of administration.

Lyxumia, which gained European and Japanese marketing approval earlier this year (The Pharma Letter February 4 and June 28), was in-licensed from Denmark-based Zealand Pharma (Nasdaq OMX Copenhagen: ZEAL). Sanofi plans to resubmit the New Drug Application for lixisenatide in the USA in 2015, after completion of the ELIXA cardiovascular outcomes study. The company recently withdrew the US NDA pending this study (The Pharma Letter September 18).

“Helping patients reach their HbA1c goal is the main objective of type 2 diabetes treatment,” said Bo Ahren, a professor at the Faculty of Medicine, Lund University, Sweden. “Flexibility in timing of administration is also an important attribute, especially for injectable diabetes therapies. This study shows that once-daily lixisenatide meets these criteria, which is significant for an agent that is prescribed for use in combination with existing treatment regimens,” he added.