VIVUS is on track to file this IND in the first half of 2018.
CAMPBELL, CA--(Marketwired - November 02, 2017) - VIVUS (VVUS) (the "Company"), a biopharmaceutical company committed to the development and commercialization of innovative therapies focusing on treatments for patients with serious unmet medical needs, today announced that it held a pre-IND meeting with the U.S. Food and Drug Administration (FDA) in October for its proprietary formulation of tacrolimus for the treatment of pulmonary arterial hypertension (PAH). 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."
PAH is a degenerative disease that makes it difficult for the heart to pump blood to the lungs to be oxygenated and may ultimately lead to heart failure. Current PAH treatment options only address the symptoms, slowing but not preventing disease progression. New therapies that address the underlying cause of disease are urgently needed. VIVUS is developing a proprietary formulation of tacrolimus for the treatment of PAH.
The FDA approved tacrolimus in 1994 for use in lowering the risk of organ rejection in patients undergoing kidney transplant, and is currently indicated for use in additional organ transplant settings and to treat atopic dermatitis. Tacrolimus has been shown to increase signaling through the bone morphogenetic protein receptor 2 (BMPR2) pathway, which is down-regulated in PAH patients.
About VIVUS
VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about the company, please visit www.vivus.com.
