FDA approves Eisai Medical’s Banzel for treating epileptic seizures
ROCKVILLE, Md. The Food and Drug Administration said Thursday that it had approved a new drug for use as an add-on treatment for seizures associated with a severe form of epilepsy.
The drug, Eisai Medical Research’s Banzel (rufinamide), treats Lennox-Gastaut syndrome. Lennox-Gastaut syndrome causes periods of frequent seizures mixed with brief, seizure-free periods, and most children with the disease experience impaired intellectual functioning, developmental delays and behavioral disturbances.
“This approval offers another treatment option for patients who suffer from these debilitating, severe seizures,” said Russell Katz, director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research.
In a four-month clinical trial studying patients ages 4 to 30, patients taking Banzel had improved seizure control when compared to those taking placebo, the FDA said in a statement.
Amgen, Takeda cancer drug trials stopped after deaths
NEW YORK Several deaths have brought phase 3 clinical trials of a cancer drug by Amgen and Takeda Pharmaceutical to a halt.
The two companies are investigating the drug, motesanib, as an initial treatment for small-cell lung cancer, to be used in conjunction with chemotherapy.
A committee monitoring the 600-patient study found more had died early using the drug than those receiving placebo.
“While we are disappointed in the outcome, it is consistent with data seen with some other anti-VEGF therapies and appears to constitute a class effect of these types of agents,” Amgen executive vice president for research and development Roger Perlmutter said in a statement.
Elan appoints Paya as president
SOUTH SAN FRANCISCO, Calif. Elan Corp. has appointed Carlos Paya as president, the company announced Thursday.
Paya will work from Elan?s South San Francisco, Calif., campus, focusing on leading the company’s scientific, clinical and medical initiatives.
“As an immunologist, a former vice dean of clinical investigation at the Mayo Clinic and as a successful industry executive, Dr. Paya has a unique set of attributes and experiences that perfectly match the opportunities and challenges facing Elan,” said Elan chairman of the board Kyran McLaughlin in a statement.
Paya previously worked at Eli Lilly & Co. as vice president of Lilly Research Labs and global leader of the Diabetes and Endocrine Platform. He had served as an executive at Lilly since 2001. He also worked for six years at the Mayo Clinic as professor of medicine, immunology and pathology, in addition to his position as vice dean.