Astellas Pharma Europe Ltd.

Andreas Johannis Karas

Christopher Mark Longshaw

Leticia Delgado-Herrera

Bernhardt George Zeiher

The present inventors provides one or more of a tiacumicin compound, a stereo-isomer thereof, a polymorph thereof or a pharmaceutically acceptable solvate thereof for use in the oral treatment ofinfections (CDI) or-associated disease (CDAD) in a patient according to a dosage regimen comprising: (1) administering to the patient in an initial course of treatment 200 mg of the tiacumicin compound twice a day; (2) monitoring the efficacy of the initial course of treatment in the patient by means of monitoring changes of one or more indicators of CDI or CDAD; (3) assessing whether there is a positive change of the one or the more of the indicators; and (4) switching to an intermittent course of treatment by administering to the patient 200 mg of the tiacumicin compound every other day if the one or the more of the indicators of CDI or CDAD are positively changed. Further the invention provides the use of the tiacumicin compound to reduce recurrence in a patient suffering from CDI or CDAD.

Dosage regimen for a tiacumicin compound

A tiacumicin compound, a stereo-isomer thereof, a polymorph thereof or a pharmaceutically acceptable solvate thereof, and a pharmaceutical composition, containing a tiacumicin compound, a stereo-isomer thereof, a polymorph thereof or a pharmaceutically acceptable solvate thereof, are provided for use in the oral treatment ofinfections (CDI) orassociated diarrhea or disease (CDAD) in a patient in accordance with a dosage regimen selected from the group consisting of:

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Surrey, United Kingdom

Andreas Johannis Karas