Once-weekly taspoglutide, Roche's bid to diversify into the diabetes market, controlled blood glucose as well as or better than more frequent treatments with Sanofi-Aventis' Lantus (insulin glargine), Lilly/Amylin/Alkermes' Byetta (twice-daily exenatide) or Merck's Januvia (sitagliptin) in Phase III studies reported at the American Diabetes Association scientific sessions in Orlando, Fla., June 26 (1Health News Daily, June 29, 2010). Compared to Januvia and Lantus, taspoglutide patients also lost significantly more weight, while the performance on that measure was about the same as with Byetta. Safety data from those same trials, however, gave new weight to the announcement earlier in the month that Roche has instituted a risk management plan in its Phase III trials in response to hypersensitivity reactions connected to the glucagon-like peptide-1 analogue (2"The Pink Sheet" DAILY, June 18, 2010). In three studies, patients taking taspoglutide had a significantly greater incidence of nausea and vomiting, as well as injection site skin reactions, compared to those taking comparator drugs. Data presented were from the first 24 weeks of 52-week trials; the full report will be available later in the year, when Roche hopes to have a better handle on the product's safety profile
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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