This article is more than 5 years old. Information may no longer be current.
Shire submits new drug application for lifitegrast
Robert Dempsey shares his thoughts on the company’s growth opportunities and its application for lifitegrast.
Click Here to Manage Email Alerts
Shire Pharmaceuticals has submitted a new drug application to the FDA for lifitegrast for the treatment of dry eye disease in adults.
“It is a very exciting time for the organization,” Robert Dempsey, leader of Shire’s Ophthalmics Business Unit, told Healio.com/OSN at Hawaiian Eye 2015. “As we are in the process of filing a new drug application for lifitegrast for the treatment of dry eye disease, we are, in support of this file, building out the commercial, research and development, and medical affairs infrastructure.”
Lifitegrast was acquired by Shire during the development of its phase 3 trials in March 2013. The submission is based on results from four clinical trials, which included one phase 2 study, two phase 3 efficacy and safety studies, and one long-term phase 3 safety study, according to a company press release. More than 1,800 subjects were involved in the studies.
The application comes after Shire formed an Ophthalmics Business Unit in order to focus on the commercialization of its ophthalmics pipeline products, according to a company press release.
“The company is also looking at building out the Ophthalmics [Business Unit], in addition to dry eye, in looking at opportunities in the anterior segment as well as the posterior segment to supplement our own organization’s commitment to the eye care space,” Dempsey said.
Shire also received fast track designation from the FDA for SHP607, a protein replacement therapy for the prevention of retinopathy of prematurity, according to a press release. The drug entered a phase 2 study in December 2014.
Overall product sales for Shire grew 23% to $5.8 billion in 2014, while total revenues increased 22% to $6 billion last year. The company anticipates further growth in 2015 with 21 distinct programs in clinical development, the release said.
“We look forward to building,” Dempsey said. “We look forward to growing, we look forward to investing into the eye care space, and hopefully at this time next year we’ll have more of an update on where we stand from a commercial standpoint.” – by Kristie L. Kahl and David W. Mullin
Reference:
Shire executive gives update on company progress. www.healio.com/ophthalmology/ophthalmic-business/news/online/%7Bd7c139b9-78ad-4e0a-8a17-82faa9e77c7e%7D/video-shire-executive-gives-update-on-company-progress?ecp=. Posted Jan. 23, 2015. Accessed Feb. 19, 2015.For more information:
Robert Dempsey can be reached at Shire Pharmaceuticals, Shire Way, Lexington, MA 02421.Disclosure: Dempsey reports he is the leader of Shire’s Ophthalmics Business Unit.