Two German companies are the recipients of the first opinions on paediatric investigation plans (PIPs) adopted by the European Medicines Agency’s Paediatric Committee (PDCO).

One is the German subsidiary of Japan’s Astellas while the other is medac Gesellschaft für Klinische Spezialpräparate mbH, a privately held company that specialises in oncology and autoimmune diseases. The PIP opinions relate to Astellas Pharma GmbH’s immunological product tacrolimus and medac’s anticancer L-asparaginase.

Further details will be available when the opinions are converted into EMEA decisions and published on the agency’s website. Medac’s L-aspaaginase has orphan product designation in the EU for the treatment of acute lymphoblastic leukaemia.

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 regulation on medicinal products for paediatric use (No. 1901/2006) that took effect across the European Union in January 2007. The PDCO held its first meeting at the EMEA last July.

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.

The PDCO adopted opinions on six product-specific waivers at its December meeting, covering the following products:

- Novartis Europharm’s indacaterol maleate, glycopyrronium bromide and the combination of indacaterol maleate plus glycopyrronium bromide, all for pneumology indications.
- Boehringer Ingelheim International’s telmisartan/ramipril, in the field of cardiology.
- GlaxoSmithKline R&D’s rosiglitazone maleate (neurology).
- Novartis Europharm’s panobinostat (oncology).

In addition, the EMEA has now adopted decisions on product-specific waivers for three medicines.

These are AstraZeneca’s Atacand Plus (candesartan/hydrochlorothiazide) oral tablets for essential hypertension, on the grounds that the product did not offer any significant therapeutic benefit over existing treatments for paediatric patients; Takeda’s Blopress Comp oral tablets (also candesartan/hydrochlorothiazide), for the same reason; and Novartis’ everolimus (Certican) oral tablets for renal cell carcinoma and pancreatic neuroendocrine tumours, conditions that were deemed to occur only in adult populations.