EMEA's PDCO thumbs-up to eight PIPs

At its late October meeting, the European Medicines Agency's (EMEA) Pediatric Committee adopted positive opinions on pediatric investigation plans for several drugs, including, Swiss drug major Novartis' potential cancer product everolimus.

PIPs were also granted for the endocrinology drug TGplPTH1-34 from Kuros Biosurgery International AG; Amsterdam Molecular Therapeutics' alipogene tiparvovec for cardiovascular diseases; Human Normal Immunoglobulin, from LFB Biotechnologies, in the therapeutic area of immunology and rheumatology; Novartis' gastroenterology product telbivudine; world drug giant Pfizer's HIV drug maraviroc; and Wyeth's first-in-class antibiotic tigecycline.

The PDCO also adopted a negative opinion on a PIP from US drug major Merck & Co for type 2 diabetes drug sitagliptin phosphate monohydrate in combination with metformin HCl, which is sold as Janumet.