Vertex Pharmaceuticals announced that Reshma Kewalramani will be the new chief medical officer and executive vice president, Global Medicines Development and Medical Affairs
Vertex Pharmaceuticals announced that Reshma Kewalramani will be the new chief medical officer and executive vice president, Global Medicines Development and Medical Affairs. She is currently senior vice president, Clinical Development and Medical Affairs. Kewalramani is replacing Jeffrey Chodakewitz, who is retiring, but will remain with the company as a senior advisor through early 2019.
Prior to joining Vertex in February 2017, Kewalramani was at Amgen for more than 12 years. She was most recently Amgen’s vice president and Head of the U.S. Medical Organization. She is also the industry representative to the U.S. Food and Drug Administration (FDA)’s Endocrine and Metabolic Drug Advisory Committee, and on the inaugural board of directors of the Kidney Health Initiative. She finished her internship and residency in Internal Medicine at the Massachusetts General Hospital and her fellowship in Nephrology at the Massachusetts General Hospital and Brigham and Women’s Hospital combined program. She received her medical degree with honors from the Boston University School of Medicine. She is also an alumnus of the Harvard Business School.
“I would like to personally thank Jeff for his leadership and dedication to improving the lives of people with cystic fibrosis and other serious and life-threatening diseases,” said Jeffrey Leiden, Vertex’s chairman, president and chief executive officer, in a statement. “He has played a critical role in leading multiple successful clinical development efforts at Vertex, and I’m pleased that we will continue to benefit from his guidance as a senior advisor over the next year as he transitions to retirement. I’m also delighted that Reshma has agreed to succeed Jeff as our chief medical officer. Reshma’s depth of medical knowledge, paired with her experience and proven track record as a clinical leader at Vertex, makes her an ideal successor to Jeff. I look forward to working with Reshma to continue to advance our clinical development pipeline in cystic fibrosis and other serious diseases.”
Just last week, Vertex announced it was starting its first Phase III clinical trial of VX-659, a triple combination of VX-659, tezacaftor and ivacaftor for cystic fibrosis (CF) in patients with one F508del mutation and one minimal function mutation. The trial will enroll 360 patients. The primary endpoint is the mean absolute change from baseline in percent predicted forced expiratory volume in one second (ppFEV1) at the fourth week of treatment.
Vertex believes that the three-drug cocktail has the potential to treat up to 90 percent of patients with CF, compared to 45 percent of patients that can be treated with the three commercially-available CF drugs.
The triple combination drug is made up of Kalydeco, which was approved for CF in 2012, and tezacaftor and VX-659. On February 12, the U.S. Food and Drug Administration (FDA) approved the company’s double-combination, Symdeko (tezacaftor/ivacaftor and ivacaftor) for CF in individuals ages 12 and older with two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or who have at least one mutation that is responsive to tezacaftor/ivacaftor.
“Our goal is to bring the best triple combination to patients as rapidly as possible, and this first Phase III study of VX-659 in combination with tezacaftor and ivacaftor is a significant step toward that goal,” said Chodakewitz, in a statement. “We’re pleased to initiate this study and look forward to working closely with the CF community to advance our two different triple combination regimens through Phase III development.”
Of taking over the role of chief medical officer, Kewalramani said in a statement, “It’s a privilege to work at a company with such a relentless focus on science and deep commitment to improving the lives of patients and their families. I am excited to assume the role of CMO and continue our important work to help more people with cystic fibrosis and other serious diseases alongside the talented team at Vertex.”
