Genzyme fails to win FDA approval for MS drug Lemtrada
CAMBRIDGE, Mass. — The Food and Drug Administration has declined to approve a drug made by Genzyme Corp. for certain forms of multiple sclerosis, the company said Monday.
Genzyme, a subsidiary of French drug maker Sanofi, said it received a complete response letter from the FDA for Lemtrada (alemtuzumab) as a treatment for relapsing MS. A complete response letter means that the FDA has finished reviewing a regulatory application, but can’t approve it due to questions that remain. In Genzyme’s case, the FDA said the company had not submitted sufficient evidence demonstrating that Lemtrada’s benefits outweigh serious potential side effects, and that it needs at least one clinical trial of a different design from the ones already performed.
"We are extremely disappointed with the outcome of the review and the implications for patients in the U.s. suffering with multiple sclerosis who remain in need of alternative therapies to manage a devastating disease," Genzyme president and CEO David Meeker said. "We strongly believe that the clinical development program, which was designed to demonstrate how Lemtrada compares against an active comparator as opposed to placebo, provides robust evidence of efficacy and a favorable benefit-risk profile."
Genzyme said it "strongly disagrees" with the agency’s decision and plans to appeal it, adding that its goal of gaining U.S. approval for the drug by March 31 will not be met. Lemtrada is already approved in the European Union, Canada and Australia.
"This evidence was also the basis for the approvals of Lemtrada by other regulatory agencies around the world," Meeker said, referring to the existing clinical trials.
Sanofi’s stock fell by 0.87% to $52.34 per share Monday morning on the New York Stock Exchange, following the news.
Lemtrada was a centerpiece of Sanofi’s $20.1 billion purchase of Genzyme in 2011, with Genzyme shareholders set to receive milestone payments related to the drug. Genzyme, which had become a leader in treatments for rare diseases but had run into production problems, had been an attractive acquisition target for Sanofi, then known as Sanofi-Aventis, since 2010, and the French drug maker said it planned to make Genzyme its "global center for excellence" in rare diseases.
Stayhealthy gets license from Health Canada
MONROVIA, Calif. — Regulators in Canada have given a maker of health kiosks the green light to start marketing its products there.
Stayhealthy said Health Canada’s Medical Devices Bureau had granted it a license to sell its HealthCenter Kiosk, models 650 and 650-C. The kiosks measure blood pressure, heart rate, total body weight, body-mass index, total body composition and vision and can incorporate data on blood glucose.
"With Health Canada’s approval of our clinical-grade HealthCenters, final negotiations can proceed with several key prospective partnerships, which have been ongoing," Stayhealth CEO John Collins said. "We are pleased to expand our products and services into the Canadian market, which has similar challenges and opportunities as the United States."
Gilead’s Complera approved for HIV patients already on stable drug regimens
FOSTER CITY, Calif. — The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.
Gilead said the FDA approved its single-pill regimen, Complera (emtricitabine; rilpivirine; tenofovir disoproxil fumarate) for use in adult patients who have suppressed their infections on stable antiretroviral regimens and are replacing their current regimens. The FDA originally approved the drug in 2011.
"Complera is an effective single-pill therapy with a demonstrated safety profile and has rapidly become an important option for appropriate HIV patients who are initiating antiretroviral treatment," Community Research Initiative of New England research director and Complera clinical trial investigator Calvin Cohen said in a statement on behalf of Gilead.