Meeting highlights from the Paediatric Committee: 09 -11 December 2009
Opinions on paediatric investigation plans
The Paediatric Committee (PDCO) adopted opinions agreeing paediatric investigation plans (PIPs) for the following medicines:
• Teplizumab, from Eli Lilly and Company Limited, in the therapeutic area of endocrinology-gynaecology-fertility-metabolism;
• Givinostat, from Italfarmaco SpA, in the therapeutic area of endocrinology-gynaecology- fertility-metabolism;
• (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S, 23S,26R,27R,34aS)- 9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-
1,4,5,6,9,10,11,12,13,14,21,22, 23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyldimethyl-phosphinate (also known as : MK-8669 or AP23573), from Merck Sharp and Dohme (Europe), Inc., in the therapeutic area of oncology;
• Japanese encephalitis virus (strain SA14-14-2 (inactivated)), from Intercell AG, in the therapeutic area of vaccines.
Opinions on product-specific waivers
The PDCO adopted positive opinions for product-specific waivers, recommending that the obligation to submit data obtained through clinical studies with children be waived in all subsets of the paediatric population, for the following medicines:
• (D-6-n-propyl-8β-ergolinylmethylthioacetyl)-DLys(D-6-n-propyl-8β- ergolinylmethylthioacetyl)-Cys-Tyr-DTrp-Lys-Abu-Cys-Thr-NH2 (BIM 23A760), from
Ipsen Pharma, in the therapeutic area of endocrinology-gynaecology-fertility-metabolism;
• Linagliptin / metformin, from Boehringer Ingelheim International GmbH, in the therapeutic area of endocrinology-gynaecology-fertility-metabolism;
• Larvae of Lucilia sericata, from ZooBiotic Limited, in the therapeutic area of other (woundcare);
• Atorvastatin (L-lysine salt) / amlodipine besilate, from Gedeon Richter Plc., in the therapeutic area of cardiovascular diseases;
• Amlodipine besylate / valsartan / hydrchlorothiazide, from Novartis Europharm Ltd., in the therapeutic area of cardiovascular diseases.
Waivers can be issued if there is evidence that the medicine concerned is likely to be ineffective or unsafe in the paediatric population, or that the disease or condition targeted occurs only in adult populations, or that the medicine, or the performance of trials, does not represent a significant
therapeutic benefit over existing treatments for paediatric patients.
Opinions on modifications to an agreed PIP
The PDCO also adopts, every month, opinions on modifications to an agreed PIP, which can be requested by the applicant when the plan is no longer appropriate or when there are difficulties that render the plan unworkable.
Withdrawals
The PDCO noted that 6 applications, of which 2 were requests for modifications to agreed PIPs, were withdrawn during the late stages of the evaluation (30 days or less before opinion).
Interaction with external experts
The PDCO has regular interactions with academic experts, with a view to bringing state-of-the-art knowledge to the PDCO scientific discussions. Two experts were invited to the December meeting with a clinical expertise in paediatric neurology to discuss specific products intended to treat epilepsy and sleep disorders.
The next meeting of the PDCO will be held on 13-15 January 2010.