Opinions on paediatric investigation plans (PIPs) continue to roll out of the European Medicines Agency’s (EMEA) Paediatric Committee, with four positive assessments adopted at the PDCO’s most recent meeting earlier this month.

The committee’s latest opinions relate to PIPs for:

- Johnson & Johnson PRD’s broad-spectrum carbapenem antibiotic, doripenem monohydrate (Doribax), in the therapeutic field of infectious diseases
- Heidelberg Pharma’s flosfluridine tidoxil, an investigational once-daily oral treatment for actinic keratosis, colorectal cancer and breast cancer, in the field of dermatology
- Janssen Cilag International’s atypical antipsychotic, paliperidone (INVEGA), in the field of psychiatry
- Aventis Pharma SA’s anticancer, docetaxel (Taxotere), in the field of oncology.

Further details on the PIPs will be available once the opinions are converted into EMEA decisions and published on the agency’s website.

Adopting opinions on PIPs, as well as applications for waivers and deferrals from the plan’s requirements, is the main function of the committee set up under the EU’s regulation on medicinal products for paediatric use (No. 1901/2006), which took effect in January 2007. The PDCO held its first meeting at the EMEA last July and adopted its first opinions on two PIPs last December.

At its January meeting, the paediatrics committee adopted opinions on PIPs for Merck Sharp and Dohme Ltd’s antihypertensive, losartan (Cozaar), in the field of cardiology; Merck Sharp and Dohme Ltd’s asthma/seasonal allergic rhinitis therapy, montelukast (Singulair), for a pneumology indication; Pfiizer Global Research and Development’s glaucoma treatment, latanoprost (Xalatan), in the ophthalmology field; and Merck Sharp and Dohme Ltd’s antifungal, caspofungin (Cancidas), in the therapeutic area of infectious diseases.

Under the paediatric regulation, companies seeking approval either for a new medicinal product or for a new indication, route of administration or pharmaceutical form of an existing patent-protected product must submit a PIP detailing their strategy for developing the drug in all subsets of the paediatric population. The trade-off for meeting the requirements of an agreed PIP is a six-month extension to the product’s supplementary protection certificate.

Waivers from these obligations are available where there is evidence that the drug or class of drugs is likely to be ineffective or unsafe in part or all of the paediatric population; the disease or condition targeted by the product occurs only in adult populations (‘class waivers’); or the drug concerned does not present a significant therapeutic benefit over existing treatments for paediatric patients.

Product-specific waivers
At its February meeting, the PDCO adopted a product-specific waiver for NicOx S.A.’s anti-inflammatory, Naproxcinod (naproxen nitrooxybutylester), in the field of rheumatology, recommending that the obligation to submit data from clinical trials with children should be waived for all subsets of the paediatric population.

The Committee also noted that the EMEA had taken up its positive opinion from last December on a PIP for medac Gesellschaft für Klinische Spezialpräparate’s anticancer, L-asparaginase. The plan relates to clinical trials for the indications acute lymphoblastic leukaemia and lymphoblastic lymphoma.

In addition, the EMEA adopted decisions on product-specific waivers in all subsets of the paediatric population for telmisartan/ramipril, rosiglitazone maleate, panobinostat, indacaterol maleate, glycopyrronium bromide and indacaterol maleate/glycopyrronium bromide. All of these decisions may be viewed on the agency’s website at www.emea.europa.eu/htms/human/paediatrics/decisions.htm.

To date, a total of 117 validated PIPs/waiver applications have been submitted under the EU regulation, 64 (55%) of which are for as yet unapproved drugs; 52 for new indications, pharmaceutical forms or routes of administration for already approved and patent-protected products; and one of which was for an off-patent drug developed specifically for children in an age-appropriate formulation.