Nearly four years after the FDA rejected Takeda’s attempt to develop a subcutaneous formulation of blockbuster Entyvio (vedolizumab), the Japanese company has won the regulator over with its second-chance effort.
On Wednesday, the FDA signed off on Takeda’s subcutaneous version of Entyvio to be used as a maintenance therapy for patients with moderately to severely active ulcerative colitis (UC). The nod makes Entyvio the only biologic treatment for UC that can be administered intravenously or subcutaneously in the United States, Brandon Monk, the head of Takeda’s U.S. gastroenterology business, said in a statement.
Takeda expects the single-dose, pre-filled Entyvio pens to become available by the end of October. The 108 mg dose can be used for maintenance every two weeks after induction, which includes two IV doses, also administered two weeks apart.
An alternate form of administration may help Takeda compete against newer UC drugs such as Johnson & Johnson’s Stelara and AbbVie’s Skyrizi, which are already available subcutaneously.
The endorsement was supported by a phase 3 trial of 162 patients who had achieved clinical response after six weeks of induction therapy. Eligible patients included those who had demonstrated an inadequate response or intolerance to corticosteroids, immunomodulators or anti-tumor necrosis factor (TNF) blockers.
Subcutaneous Entyvio outperformed placebo at Week 52, with 46% of patients achieving remission on the treatment. That compared to 14% in the control arm.
The FDA originally approved Entyvio for treatment and maintenance of patients with UC or Crohn’s disease in 2014. Takeda also is seeking a nod from the regulator for its subcutaneous version of the drug in Crohn’s disease. The FDA accepted that application earlier this month. The company’s trial of 409 patients in the indication produced similar results.
Takeda’s subcutaneous version has already been approved in Europe and Japan. It was rejected by the FDA in December 2019 because of the design of its injection device.
Entyvio sales have increased significantly in recent years, reaching $6.4 billion last year. In October of 2022, the company projected peak sales to reach between $7.5 billion and $9 billion. Biosimilar versions of Entyvio are not expected to reach the U.S. until 2032.