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Lilly wins FDA nod for Humalog pre-filled Junior KwikPen device

June 14, 2017 By Sarah Faulkner

Eli LillyEli Lilly (NYSE:LLY) said today that the FDA approved its Humalog Junior KwikPen for the treatment of diabetes.

The device is a pre-filled pen with half-unit dosing capabilities, which Eli Lilly said gives patients access to finer dose adjustment.

“We are pleased to be able to meet the needs of people who prefer a prefilled insulin pen but require the fine-tuning that half-unit dosing provides. The pre-filled Humalog Junior KwikPen can help make insulin injections easier to incorporate into their everyday lives,” Lilly Diabetes’ VP of global medical affairs, Dr. Sherry Martin, said in prepared remarks. “This latest approval speaks to Lilly Diabetes’ commitment to making lives of people affected by diabetes better.”

The company said it expects the Humalog Junior KwikPen to hit U.S. pharmacies later this year. Lilly is also seeking regulatory approval for the half-unit dosing device in the European Union.

In April, the company met expectations on Wall Street with its 1st quarter financial results. Lilly’s diabetes therapies, including Humalog, helped to propel the company to an adjusted quarterly profit that beat expectations on The Street.

“We are encouraged by another solid performance from Lilly’s overall diabetes franchise,” Leerink Partners analyst Seamus Fernandez said in a note, according to Reuters.

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Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Wall Street Beat Tagged With: Eli Lilly & Co.

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