Merck, Sanofi commence late-stage trial for childhood diseases vaccine
WHITEHOUSE STATION, N.J. — Merck and Sanofi Pasteur have started a late-stage clinical trial of a combination vaccine for six childhood diseases, the companies said Thursday.
The companies announced a phase-3 trial of the vaccine for diphtheria, tetanus, whooping cough, polio, hepatitis B and invasive disease caused by Haemophilus influenzae type b. The trial will involve about 1,440 infants at multiple centers, with the primary goal of assessing safety and immunogenicity compared with Pfizer’s pneumococcal disease vaccine Prevnar 13 and Merck’s rotavirus vaccine RotaTeq.
“Combination vaccines simplify the childhood immunization schedule and may improve coverage [and] on-time vaccination, and [may] reduce the number of injections for children,” University of Louisville School of Medicine professor of pediatrics Gary Marshall said on behalf of the companies.
GSK, Valeant respond to CRL for ezogabine
LONDON — GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration’s complete response letter for the companies’ investigational anti-epileptic drug.
GSK and Valeant said that their new drug application for ezogabine, an investigational anti-epileptic drug being studied for the adjunctive treatment of adults with partial-onset seizures, was not approved by the FDA, and said they received the CRL on Nov. 30, 2010. Last August, the FDA announced it pushed back its review of ezogabine after a formal risk evaluation and mitigation strategy was submitted to the agency from GSK and Valeant, per its request.
The FDA issues a CRL when it has finished reviewing the application for a drug but issues remain that preclude final approval.
Report: Lupin’s generic Fortamet receives FDA nod
NEW DELHI — The Food and Drug Administration has approved a diabetes drug made by Lupin Pharmaceuticals, according to published reports.
The FDA approved Lupin’s metformin hydrochloride extended-release tablets, a generic version of Andrx Labs’ Fortamet.
Fortamet had sales of $83 million in 2010, according to IMS Health.