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VIVUS announced it completed a pre-IND meeting with the FDA for its formulation of tacrolimus for the treatment of pulmonary arterial hypertension.
VIVUS (NASDAQ:VVUS) announced it completed a pre-IND meeting with the US Food and Drug Administration (FDA) for its formulation of tacrolimus for the treatment of pulmonary arterial hypertension.
As quoted in the press release:
The FDA addressed VIVUS’ questions related to preclinical, nonclinical and clinical data and planned design of clinical trials of tacrolimus in class III and IV PAH patients, and clarified the requirements needed to file an IND to initiate a clinical trial in this indication. VIVUS is on track to file this IND in the first half of 2018. As discussed with the FDA, VIVUS currently intends to design and conduct clinical trials that could qualify for Fast Track and/or Breakthrough Therapy designation.
“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,” said Seth H. Z. Fischer, VIVUS’ Chief Executive Officer. “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.”
Click here to read the full press release.
Source: www.marketwired.com
