The European Medicines Agency has been formally notified by Only For Children Pharmaceuticals of its decision to withdraw its application for a centralized marketing authorization for the medicine Loulla (mercaptopurine), 10 mg/mL, tablets and solution for oral suspension.
Loulla was intended to be used for the maintenance treatment of acute lymphoblastic leukemia. Mercaptopurine was designated an orphan medicinal product on October 22, 2007.
The application for the marketing authorization for Loulla was submitted to the Agency on 6 December 2011. At the time of the withdrawal it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).
In its withdrawal letter, the company stated that they have decided to withdraw the application because Nova Laboratories orphan medicinal product Xaluprine (mercaptopurine), similar to Loulla, was granted a European marketing authorization on March 9, 2012. Xaluprine is protected by 10 years exclusivity. Only For Children Pharmaceuticals has tried to fulfill one of the derogations criteria, as laid down in Art.8, paragraph 3 of the Commission Regulation (EC) No 847/2000, by providing a critical report claiming that Loulla was clinically superior to the authorized orphan medicinal product Xaluprine. The CHMP, however, concluded that there was insufficient evidence to support the claim of clinical superiority over Xaluprine.
More information about Loulla and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the Agency’s website after the CHMP meeting of January 14-17, 2013.
Date: December 20, 2012
Source: European Medicines Agency