Xalatan receives paediatric indication in Europe
Pfizer has announced that Xalatan (latanoprost) has been approved by the European Commission for the reduction of elevated IOP in the treatment of paediatric patients.
Pfizer has announced that Xalatan (latanoprost) has been approved by the European Commission for the reduction of elevated IOP in the treatment of paediatric patients. This is the first time that a prostaglandin analogue has completed safety and efficacy trials in a paediatric population and has been indicated for use in patients aged 18 or younger in Europe.
The EU approval has been based on Phase III and Phase I studies that were contained in Pfizer's Paediatric Investigation Plan as agreed with the European Medicines Agency (EMA) in accordance with the EU Paediatrics Medicines Regulation. As a result of its compliance with these regulations Pfizer can and will apply for a six-month patent protection extension in European countries where it currently has a Supplementary Protection Certificate (SPC).
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