Vivus announced that it is in discussions with the U.S. Food and Drug Administration (FDA) to possibly test tacrolimus — an oral medication used to prevent organ rejection after a transplant — as a potential treatment for pulmonary arterial hypertension (PAH).
In a scheduled pre-Investigational New Drug (IND) application meeting, the FDA answered the biopharmaceutical company’s questions pertaining to the development of tacrolimus (including preclinical, nonclinical and clinical work), and questions related to the design of potential clinical trials in PAH patients.
The FDA also clarified the requirements for filing this application, a necessary step to beginning studies in people.
“Our meeting with the FDA was an important step forward and the guidance we received during our pre-IND meeting was valuable in our development of clinical and regulatory strategies that will support our goal of advancing tacrolimus into and through clinical development,” Seth H. Z. Fischer, Vivus’ chief executive officer, said in a press release.
Vivus plans to file an IND in the first half of 2018, and if given the OK, to run trials that might allow tacrolimus to quality for FDA designations that would promote its development, like Fast Track and Breakthrough Therapy.
Tacrolimus, an immunosuppressant, works by increasing signaling through a cellular pathway called the bone morphogenetic protein receptor 2 (BMPR2) pathway, which is known to be less active in PAH patients. In fact, several published studies associate the loss of this pathway with PAH development.
Tacrolimus was first approved by the FDA in 1994 to reduce the risk of organ rejection in patients undergoing a kidney transplant. Currently, it is used broadly in transplants of the heart, liver and kidneys, and to treat atopic dermatitis.
“We believe that our tacrolimus development program holds great potential as an innovative therapy that can help to address the unmet clinical needs of patients living with PAH, including preventing disease progression and/or disease modification,” Fischer said.
Current PAH treatments are able to address disease symptoms of the disease, but cannot prevent progression.
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