May 18 (Reuters) - Johnson & Johnson's JNJ.N unit Janssen Pharmaceuticals said U.S. health regulators broadened the approval of its antipsychotic agent, Risperdal Consta, for the treatment of bipolar I disorder.
The drug, which has already been approved as a treatment for schizophrenia and bipolar mania, was approved as a stand-alone therapy and in addition to lithium or valproate, the current standard of care.
Type I bipolar disorder is characterized by the occurrence of at least one manic episode, with or without a major depressive episode.
In February, the company had received an approvable letter from the U.S. Food and Drug Administration, asking for additional data on Risperdal Consta.
Johnson & Johnson had applied for approval of Risperdal Consta to delay the occurrence of mood episodes in patients with bipolar disorder who relapsed frequently.
Alkermes Inc ALKS.O manufactures Risperdal Consta under an agreement with Janssen Pharmaceuticals.
Shares of Alkermes were nearly flat at $8.61 in morning trade on Nasdaq. (Reporting by Vidya L Nathan in Bangalore; Editing by Vinu Pilakkott)
Our Standards: The Thomson Reuters Trust Principles.