The FDA just rejected Allergan’s women’s health drug

Markets Insider

  • Allergan said on Tuesday that the Food and Drug Administration would not approve one of its women’s health drugs, Esmya.
  • The drug was being investigated to treat uterine fibroids, a condition characterized by benign tumors that grow in and around the uterus that can cause heavy bleeding and pain.
  • The agency cited “safety concerns regarding Esmya post-marketing reports outside the United States,” Allergan said. The drug is available in Europe, but European regulators have raised concerns about the risk of a “rare but serious liver injury” in women taking the drug.
  • Allergan said in May that it was planning to sell off its women’s-health and infectious-disease businesses, which it considered noncore to the company.
  • “While this is another setback, we believe investors will likely not be disturbed by this,” Wells Fargo analyst David Maris said in a note Wednesday.
  • The stock was down as much as 1.5% in pre-market trading Wednesday on the news.