PDCO gives word on PIPs from latest meeting

The Pediatric Committee (PDCO) of the European Medicines Agency (EMEA) has adopted positive opinions on pediatric investigation plans for the following medicines: in hematology and hemostaseology, dabigatran etexilate, from Boehringer Ingelheim, and thrombin alfa (recombinant), from Bayer HealthCare; and in neurology, pramipexole dihydrochloride monohydrate, also from Boehringer Ingelheim, and retigabine from Valeant Pharmaceuticals.

The PDCO adopted negative opinions for PIPs in endocrionology and metabolism for ezetimibe, nicotinic acid (in an extended release form), simvastatin and laropiprant, all from Merck Sharp & Dohme. The committee adopted subsequently on its own motion positive opinions on full waivers for these medicines in all subsets of the pediatric population, on the grounds, it says, that these products do not represent a significant therapeutic benefit over existing treatments for the pediatric population.