Eli Lilly and Company has taken its topical testosterone replacement therapy, Axiron, off the Korean market after the Ministry of Food and Drug Safety approved its Korean branch’s request for the drug’s withdrawal.

“We have proceeded with the voluntary withdrawal after considering various factors such as low male menopause awareness and the existence of substitutable medicines,” a Lilly Korea official said.

Eli Lilly and Company withdraws Axiron from the Korean market.

Axiron is a topical solution that contains testosterone, indicated as replacement therapy in males who have low or no testosterone due to medical conditions. Axiron is prescription medicine applied to the armpit like a roll-on deodorant.

The testosterone therapy, developed by Australian pharmaceutical Acrux and marketed by U.S.-based Eli Lilly and Company, gained U.S. FDA approval as a topical solution in 2010, and the Ministry of Food and Drug Safety’s approval in November 2013. Eli Lilly Korea launched the drug in April 2014.

Eli Lilly’s decision to withdraw Axiron from Korea parallels its decision to pull out the therapy from other countries such as Australia and the U.S. last year. The drug is currently discontinued in the U.S. as “multiple commercial manufacturers [are] supplying the U.S. market,” according to Eli Lilly’s discontinuation report made to the FDA in September 2017.

In the U.S., the company had reportedly faced increasing competition from Axiron’s generics as well as an investment-heavy request from the FDA that required post-marketing trials to assess safety concerns of testosterone therapies increasing the risk of cardiovascular diseases such as heart attacks and strokes.

Reuters reported that Eli Lilly and Company and Axiron-developer Acrux mutually terminated their licensing agreement in September last year.

yjc@docdocdoc.co.kr

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