Successful Outcome from European Clinical Pharmacokinetic Study Comparing SUBA-Itraconazole with Sporanox

HalcyGen to begin Marketing Authorisation Application for Regulators in Europe

04-Mar-2010 - Australia

HalcyGen Pharmaceuticals Limited announced that preliminary results from its UK-based pharmacokinetic study (PK) comparing a half-dose of anti-fungal drug SUBA-Itraconazole with Sporanox®, has shown clinical bioequivalence within EU guidelines. Following a pre-registration meeting with the regulatory body, HalcyGen intends to file for registration in the UK in August 2010 as a first step towards registration in the various EU territories.

On 28th August 2009 HalcyGen announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) had guided HalcyGen to undertake a single pharmacokinetic study in the European Union to demonstrate that SUBA-Itraconazole performs in a similar manner when compared to EU registered Sporanox® as it does with US derived Sporanox®. This advice concurred with guidance from the corresponding regulatory agency in Sweden.

The results of the recently completed study show that SUBA-Itraconazole given at a half dose to Sporanox® is clinically bioequivalent to Sporanox® when given according to the prescribing information. HalcyGen will seek further guidance from the MHRA as to the sufficiency of the data for registration purposes with particular emphasis on what indications will be granted under the scope of a registration. Currently, Itraconazole is registered for use in indications including: onychomycosis candidosis, aspergillosis, histoplasmosis and cryptococcosis.

https://www.bionity.com/en/news/114383/successful-outcome-from-european-clinical-pharmacokinetic-study-comparing-suba-itraconazole-with-sporanox.html