Eli Lilly & Co. has taken its topical testosterone replacement therapy Axiron off the market in Korea after gaining the blessing of the country’s Ministry of Food and Drug Safety. The company said that it made the decision to withdraw the treatment from the market in Korea due to several factors including “low male menopause awareness and the existence of substitutable medicines.”
Axiron was developed by Australian pharmaceutical company Acrux and marketed by U.S.-based Lilly. It was approved by the U.S. Food and Drug Administration (FDA) in 2010 for the treatment of hypogonadism, a condition in which men do not produce enough of the male hormone due to injury, disease or defect. Axiron was approved by Korea’s Ministry of Food and Drug Safety in November 2013, and hit the market there in 2014.
Lilly pulled Axiron from the U.S. as well as other countries, including Australia, last year, citing “multiple commercial manufacturers supplying the U.S. market.”
Not only was Eli Lilly & Co. facing growing competition from generic Axiron in the U.S., the company is also facing a slew of lawsuits as part of a multidistrict litigation naming several makers of testosterone replacement therapies for not warning the drug could incease the risk of heart attacks, strokes, blood clots and death. Two cases against AbbVie Inc., over its AndroGel testosterone treatment have been tried resulting in verdicts totaling nearly $300 million.
Lilly was to face its first two bellwether trials in the multidictrict litigation this month and in March, but announced it had reached a global settlement in all the cases. The judge overseeing the cases canceled the trial dates involving Axiron.
Korea Bio Med