HOLLISTON, Mass.--(Veristat, a leading Clinical Research Organization (CRO), applauds Aegerion Pharmaceuticals on their recent FDA approval of Juxtapid for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) (official press release.) Dr. John Balser, President of Veristat commented, “Congratulations to the Aegerion team. As a pivotal strategic partner on the biostatistical, medical writing, and regulatory strategy for this submission, we are honored to have played a part in the approval of such an important, lifesaving therapy.”)--
“Congratulations to the Aegerion team. As a pivotal strategic partner on the biostatistical, medical writing, and regulatory strategy for this submission, we are honored to have played a part in the approval of such an important, lifesaving therapy.”
HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing LDL-C ("bad" cholesterol) from the body. Patients with HoFH often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries. The FDA based its approval of Juxtapid on Aegerion's pivotal Phase 3 study, which evaluated the safety and effectiveness of the medicine to reduce LDL-C levels in 29 adult patients with HoFH.
Veristat collaborated with Aegerion as an integral part of their submission team for Juxtapid, providing strategic insight, statistical analysis, and medical writing support. Specifically, Veristat worked in partnership with Aegerion to produce the Phase 3 pivotal clinical study report, the integrated summary of safety, and all clinical summary documents for simultaneous NDA/MAA filings. “One of the most gratifying aspects of our collaboration was working hand-in-hand with Aegerion in preparation for and participation in the FDA Advisory Committee meeting, where the expert panel members voted in favor of Juxtapid’s approval,” said Dr. Balser.
“The approval of Juxtapid is a landmark event for patients with this rare disease," said Martha Carter, Chief Regulatory Officer and Senior Vice President at Aegerion. “We want to extend our gratitude to the team at Veristat for their energy, insights, and commitment to the Juxtapid program over the past few years. Veristat played a key role in the successful submission and approval of this important therapy.”
“This was a tremendously rewarding project for us,” said Dr. Barbara Balser, Executive Vice President and Chief Scientific Officer of Veristat. “Every member of the team was focused on delivering 110% to ensure a successful and timely submission for Juxtapid.” She went on to say, “The Aegerion team was, and continues to be, a great partner with Veristat. We are honored to have been invited to contribute our expertise to the critical elements of the Juxtapid submission and we continue to support Aegerion in their effort to make this important therapy available to patients worldwide.”
Veristat, Inc. is an innovative, science-focused clinical research organization (CRO) in its 20th year of providing dynamic expertise in supporting clinical trials and regulatory submissions for pharmaceutical, biotechnology, and medical device companies. Veristat offers comprehensive services, including biostatistics, statistical programming, medical writing, clinical monitoring and data management for a single study or an entire clinical program, as well as preparation of integrated summary documents and submission-ready CDISC data for regulatory filings. Due to Veristat’s unwavering commitment to scientific integrity, client focus and exceptional performance, long-lasting client relationships are our hallmark. For more information about Veristat and the services provided please visit www.veristat.com.