Mylan (MYL), Biocon Announce EMA Acceptance of Insulin Glargine MAA
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Mylan N.V. (Nasdaq: MYL) and Biocon Ltd. announced that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Application (MAA) for insulin glargine, a long-acting insulin analog used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.
Mylan and Biocon, which have co-developed insulin glargine, look forward to offering another insulin treatment option for diabetic patients, who are often facing significant expense to manage their disease.
This filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy/safety global clinical trial in Type 2 diabetes patients comparing Mylan's and Biocon's Insulin glargine with Lantus. The PK study demonstrated PK and PD bioequivalence of Mylan's and Biocon's insulin glargine relative to that of the reference drug Lantus.
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