Teva unveils mid-stage clinical trial results for MS drug
JERUSALEM Teva Pharmaceutical Industries and Active Biotech announced promising results from a mid-stage trial of laquinimod, a once-daily oral treatment for relapsing-remitting multiple sclerosis.
The companies released results of a phase-2 extension study of the drug indicating that it was safe for use in patients, but also reduced lesions that are a marker of disease activity by 52%. In addition, the study indicated that the drug reduced relapses of the disease and did not show evidence of suppression of the immune system. Results of the study were published online in the journal Multiple Sclerosis.
The two companies expect to see results of two phase-3 trials of the drug next year. The Food and Drug Administration gave fast-track designation to the drug in February 2009.
Teva receives complete response letter for Neutroval
JERUSALEM The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker said Thursday.
Teva said it received a complete response letter from the FDA concerning Neutroval (filgrastim), for neutropenia in patients receiving chemotherapy for cancer. The FDA issues complete response letters when it needs additional information before it can approve a drug.
Neutroval is a biosimilar of Amgen’s Neupogen and is marketed in Europe under the name TevaGrastim.
GSK halts Simplirix trial
LONDON British drug maker GlaxoSmithKline has stopped a late-stage trial of a vaccine for genital herpes, citing disappointing results, GSK said Thursday.
The company said that while the vaccine Simplirix (herpes simplex vaccine) proved to be safe when administered to women as a prevention for genital herpes disease, it did not prevent infection. GSK had been conducting the phase 3 trial in 8,323 women ages 18 to 30 years in the United States and Canada under a partnership with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
“We would like to express our gratitude toward our partner, [the National Institute of Allergy and Infectious Diseases], for [its] proactive collaboration and substantial contribution in the program, and the volunteers for their participation in the study,” GSK VP and director for late clinical development Gary Dubin said.