Zydax: Withdrawal of the marketing authorisation application
The applicant Parnell Technologies (UK) Limited submitted on 26 February 2016 an application for a marketing authorisation to the European Medicines Agency (The Agency) for Zydax, through the centralised procedure under Article 3(2)(a) of Regulation (EC) No 726/2004 (optional scope).
The active substance of Zydax is glucuronoxylan sulfate sodium (GXS), a semisynthetic polysaccharide with a sulfated linear xylan backbone. The compound is a member of the pentosan polysulfate sodium (PPS) family. PPS has anti-inflammatory and antiphlogistic properties and acts by modification of the intraarticular proteoglycans.
The eligibility to the centralised procedure was agreed upon by the CVMP in June 2011 (and re-confirmed in January 2016) as the Committee considered that Zydax contains a new active substance, glucuronoxylan sulfate sodium (GXS), which was not authorised as a veterinary medicinal product in the Union on the date of entry into force of Regulation (EC) No 726/2004. This decision was based on the justification provided by the applicant that there are structural differences, as well as a different mode of action resulting in a different safety and efficacy profile compared to the glycan ester compound pentosan polysulfate sodium (PPS), which is already authorised as a veterinary medicinal product in the EU. However, on the basis of the data provided and the assessment by the CVMP, the Committee later considered that there are no significant chemical differences between the two substances, and that no data have been provided confirming that GXS exerts a different mode of action to PPS.
Zydax is a solution for subcutaneous injection, which is presented in a glass vial (20 ml), containing 100 mg/ml glucuronoxylan sulfate sodium. The applicant applied for the following indication: "For the treatment of lameness, pain and mobility impairment of osteoarthritis (non-infectious arthrosis) and related musculoskeletal disorders by therapeutic activity on the underlying pathological processes (disease modifying osteoarthritis drug) in dogs.”
The applicant is registered as an SME pursuant to the definition set out in Commission Recommendation 2003/361/EC.
The dossier has been submitted in line with the requirements for submissions under Article 12(3) of Directive 2001/82/EC – full application.
On 7 February 2018, Parnell withdrew the application at day 200 of the procedure. In its letter notifying the Agency of the withdrawal of application, the applicant stated that the reason for the withdrawal are commercial reasons, as no further studies would be conducted which would be necessary for completion of the marketing authorisation.
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Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CVMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter. An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 120').