Panel Embraces Sanofi Diabetes Combo, Shuns 'Pen' Devices
While the FDA's Endocrinologic and Metabolic Drugs Advisory Committee backed approval of Sanofi SA's fixed-ratio combination type 2 diabetes medicine, many of the panelists objected to the two complicated pen devices the company is proposing to use to administer the drug – calling for them to be redesigned.
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An FDA advisory panel unanimously backed approval of Novo Nordisk AS' fixed-dose combination of Victoza (liraglutide) and Tresiba (insulin degludec), but if the agency approves the drug, it will be facing a market full of competitors and several other new products coming down the pike.
Sanofi SA's strategy of using two pen injectors for its fixed-ratio combination that combines its experimental glucagon-like peptide-1 receptor agonist lixisenatide with its US-approved diabetes drug Lantus (basal insulin glargine) has the FDA perplexed and concerned about the potential for adverse events and medication errors.
A May 24 advisory panel meeting is critical for Novo Nordisk's effort to convince the FDA to approve the Danish company's fixed-dose combination diabetes drug IDegLira – which unites Victoza (liraglutide) with Tresiba (insulin degludec) – but regulators questioned the firm's trial design.