The European Medicines Agency’s (EMEA) Paediatric Committee (PDCO) adopted positive opinions on paediatric investigation plans (PIPs) for one medicine and one vaccine at its meeting earlier this month.

The two products concerned were meningococcal group A oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein (MenA-CRM), from Novartis Vaccines and Diagnostics S.r.l; and MSD-SP Limited’s (i.e., Merck & Co/Schering-Plough) cholesterol management drug ezetimibe (Ezetrol, Zetia, Ezemibe), in the therapeutic area of endocrinology.

Further details on the PIPs will be available once the opinions are converted into EMEA decisions and published on the agency’s website. The EMEA has now taken up the following decisions on PIPs adopted by the paediatrics committee at its meeting in January:

- 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;
- Pfizer Global Research and Development’s glaucoma treatment latanoprost (Xalatan), in the ophthalmology field;
- Merck Sharp and Dohme Ltd’s antifungal caspofungin (Cancidas), in the therapeutic area of infectious diseases.

These will be published shortly on the EMEA’s website at www.emea.europe.eu/htms/human/paediatrics/decisions.htm.

Under the EU’s regulation on medicinal products for paediatric use (No. 1901/2006), 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.

At its meeting on 12-14 March, the PDCO adopted product-specific waivers for Boehringer Ingelheim GmbH’s flibanserin, an antidepressant under development as a treatment for female sexual dysfunction, in the therapeutic area of gynaecology; and for Nycomed GmbH’s roflumilast, an oral anti-inflammatory treatment for asthma/ chronic obstructive pulmonary disease, in the therapeutic area of pneumology.

In both cases the committee recommended that the obligation to submit data from clinical studies in children should be waived in all subsets of the paediatric population.

The tally of validated PIPs/waiver applications submitted under the EU regulation now stands at 145, of which 25 are requests for a full waiver.

Of the total, 85 PIPs/waiver applications (58%) are for as yet unapproved drugs, 56 (39%) for new indications, pharmaceutical forms or routes of administration for already approved and patent-protected products, and four (3%) for off-patent drugs developed specifically for children in an age-appropriate formulation.