As reported by Reuters below. Presented without comment.
FDA panel supports approval of Sanofi MS drug Lemtrada
BY DEBORAH ZABARENKO
SILVER SPRING Wed Nov 13, 2013 10:19pm GMT
(Reuters) – A federal advisory panel recommended approval of Sanofi SA’s experimental multiple sclerosis drug Lemtrada on Wednesday, but said the drug should be reserved for patients who have failed other therapies.
In a surprise decision, an advisory panel to the Food and Drug Administration voted 14 to 0, with one abstention, that the drug should be approved despite its potential to cause cancer and other serious conditions.
“Do I want to take this drug? No way!” said Dr. Nathan Fountain of the University of Virginia School of Medicine and the panel’s
chairperson. But for some patients, he said, it could be appropriate. “I wouldn’t want to deny those people,” he said.
The panel’s recommendation follows an initial report last week by reviewers for the FDA, who raised grave concerns about the drug’s potential to cause an array of autoimmune conditions, in which the body mistakenly attacks its own cells, as well as its potential to cause thyroid, skin and breast cancer.
The reviewers also questioned whether the way clinical trials of Lemtrada were conducted had biased the results in favor of the drug.
Advisory panelists, who met in Silver Spring, Maryland, said the risks could be worth it for some difficult-to-treat patients.
“The risks are very substantial, but this is a really bad disease,” said Dr. Paul Rosenberg of Johns Hopkins University School of Medicine.
Multiple sclerosis is a chronic, autoimmune disease that affects more than 2.5 million people worldwide and up to 500,000 in the United States, according to the Multiple Sclerosis Foundation. It can cause muscle weakness, pain, and speech and cognitive difficulties.
Lemtrada, which was approved in Europe in September, was at the heart of Sanofi’s lengthy, $20.1 billion takeover battle for Genzyme Corp., which developed the drug. Sanofi finally acquired Genzyme in 2011.
As part of the takeover deal, Genzyme shareholders received contingent value rights, known as CVRs, entitling them to future payments of up to $14 a share if certain goals were met, including approval for Lemtrada.
The price of the CVRs has fallen 67 percent to 66 cents since the FDA posted its review last week.
If Lemtrada, also known as alemtuzumab, is approved, it is expected to generate peak sales of $752 million by 2018, according to seven analysts polled by Thomson Reuters.
The FDA is not bound to follow the advice of its advisory committees but typically does so.
(Reporting by Deborah Zabarenko, writing by Toni Clarke; Editing by Leslie Adler)