Bay­er gets FDA nod to ex­tend use of pop­u­lar con­tra­cep­tive IUD Mire­na

Now more than ever, it’s im­por­tant for women to have op­tions when it comes to con­tra­cep­tion, said Bay­er’s se­nior VP and gen­er­al man­ag­er of women’s health­care John Berrios. The phar­ma gi­ant’s lat­est ap­proval for its pop­u­lar IUD prod­uct Mire­na should help with that.

Mire­na scored an ap­proval on Thurs­day to pre­vent preg­nan­cy for up to eight years, ex­tend­ing its use by one year. Reg­u­la­tors based their de­ci­sion on a Phase III ex­ten­sion tri­al show­ing Mire­na main­tained its ef­fi­ca­cy of greater than 99% dur­ing years 6 through 8, while ex­hibit­ing no new or un­ex­pect­ed safe­ty risks. It’s al­so ap­proved to treat heavy pe­ri­ods for up to five years.

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