A European Medicines Agency panel recommended approving a diabetes drug from Boehringer Ingelheim GmbH and Eli Lilly & Co. that was rejected this month in the U.S. because of manufacturing deficiencies.
The medicine, Jardiance, should be approved as a treatment for type 2 diabetes, the agency’s Committee for Medicinal Products for Human Use said in a statement today. The European Commission usually follows the panel’s advice.
The Food and Drug Administration said this month it wouldn’t approve the drug until Boehringer fixes the problems disclosed in May after a 2012 inspection of a plant in Ingelheim am Rhein, Germany, where the closely held company is based. The FDA completed its re-inspection of Boehringer’s plant on March 7, the company said today.
The treatment, also known as empagliflozin, is part of a class of medicines that includes Johnson & Johnson (JNJ)’s Invokana and AstraZeneca Plc (AZN)’s Forxiga. The drugs help the body get rid of sugar through the kidneys. Type 2 diabetes, the most common kind, is often driven by obesity, as the body loses its ability to process sugar. The disease may be the seventh leading cause of death in the world by 2030, according to the World Health Organization.
Lilly will garner $518 million in sales from Jardiance in 2019, according to the average of five analyst estimates compiled by Bloomberg.
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