Takeda receives CHMP backing for Revestive approval
25 June 2012 11:36 in Pharmaceutical Company Product News
Takeda has been granted a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its short bowel syndrome (SBS) therapy Revestive.
The committee has adopted a positive opinion on the approval of Revestive as a once-daily treatment for adult patients with SBS, a rare disease that impairs the body's ability to absorb nutrients and fluids after a portion of small intestine has been removed.
Data from the Steps phase III clinical trial showed that Takeda's teduglutide-based therapy offers significant benefits compared to placebo, helping patients to reduce their parenteral nutrition requirements.
Trevor Smith, head of commercial operations for Takeda in Europe and Canada, said: "We welcome the positive opinion from the CHMP for teduglutide. This is good news for patients with SBS."
Last week, the company announced that two of its new combination treatments for type 2 diabetes have been accepted for review by the European Medicines Agency.
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