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Expanded Access Policy

LEO Pharma works in alignment with health authorities to conduct clinical trials that address unmet medical needs and make new therapies available to patients as quickly as possible.

Eligibility Criteria for Expanded Access

 

All requests for access to LEO Pharma medicines must be unsolicited and made by the patient’s treating physician. Each request will be assessed on a case-by-case basis. LEO Pharma will consider granting access to its medicines when the following eligibility criteria are met.

 

Expanded access may be appropriate when all the following apply:

  • Patient has a serious or immediately life-threatening disease or condition.
  • There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
  • Patient enrollment in a clinical trial is not possible.
  • Potential patient benefit justifies the potential risks of treatment.
  • Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

Expanded Access Policy

 

Consistent with LEO Pharma’s mission to help people achieve healthy skin, LEO Pharma is dedicated to developing new therapies that have a positive impact on patient health. 

 

LEO Pharma works in alignment with health authorities to conduct clinical trials that address unmet medical needs and make new therapies available to patients as quickly as possible.

 

Information about LEO Pharma’s clinical trials, including eligibility and locations, is available at clinicaltrials.gov.  LEO Pharma recognizes the importance of Expanded Access Programs and may update this policy based on data from ongoing drug development programs and future clinical trials.

 

Expanded access requests may be submitted by a licensed physician to LEO Pharma’s Medical Information department at globalmedicglobalmedical_info_dk@leo-pharma.com LEO Pharma plans to acknowledge the receipt of specific inquiries within five (5) business days.