Oct 4 Biogen Idec's hot-selling new
multiple sclerosis drug Tecfidera remained effective for
patients taking the medicine for at least four years with no new
safety problems, according to interim data from a long-term
Tecfidera, which analysts expect to eventually dominate the
MS market, had sales of $192 million in its first quarter on the
market - nearly triple average Wall Street expectations.
The Endorse extension study followed patients who had taken
part in two pivotal Phase III trials that led to the U.S.
approval of Tecfidera.
The drug maintained its ability to reduce disease activity
as measured by relapses and disease progression in patients
treated for four years, the interim data showed.
In addition, there were no new or worsening safety problems
observed even in patients taking Tecfidera for up to six and a
half years, according to the interim analysis presented on
Friday at a major multiple sclerosis medical meeting in
Patients in the extension study also experienced a low
frequency of new MS brain lesions similar to what had been
observed after two years.
"These interim Endorse findings reaffirm, over the longer
term, the outcomes we have previously observed with Tecfidera
and provide important information for physicians and patients,"
Dr. Ralf Gold, chairman of the department of neurology at St.
Josef Hospital in Bochum, Germany, said in a statement.
There was no increased risk of serious infections or cancers
and no overall increased risk of kidney dysfunction or liver
problems seen in the long-term study, Biogen said.
Patients in the earlier two-year Phase III studies who had
been in the control groups that received either a placebo or
Copaxone - the current MS market leader from Teva Pharmaceutical
Industries - were given Tecfidera in the Enforce
extension trial. They had similar favorable clinical responses
as those who had received the Biogen drug in the earlier trials,
the company said.
In those studies, Tecfidera led to a 54 percent reduction in
the risk of MS relapse compared with placebo.
Researchers will continue to follow the 1,738 patients with
relapsing-remitting multiple sclerosis (RRMS) in the Endorse
trial. They are receiving 240 milligrams of Tecfidera either two
or three times a day.
About two million people suffer from MS worldwide. RRMS is
the most common form of the disease, characterized by episodes
of worsening neurologic function followed by periods of
remission involving partial or complete recovery, according to
the Multiple Sclerosis International Federation.