Sanofi's 2-Pen Diabetes Combo Perplexes FDA
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.
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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.
Sanofi has filed a new drug application (NDA) with the US FDA for LixiLan, its investigational fixed-ratio combination of insulin glargine (Lantus) and the GLP-1 receptor agonist lixisenatide (Lyxumia). Sanofi also revealed that it redeemed a priority review voucher (PRV) with the filing, giving the NDA an expedited 6-month review if the submission is accepted by the FDA, instead of the standard 10-month review.
Eli Lilly & Co. and its partner Boehringer Ingelheim GmbH won the first-ever US approval of a follow-on version of Sanofi SA's Lantus (insulin glargine) – a clearance for marketing that was permitted under the FDA's 505(b)(2) abbreviated pathway, which permits an application to rely, in part, on safety and efficacy data from an innovator's product.