Clinical trials must be conducted in order to establish the efficacy, safety and tolerability of an investigational treatment. The U.S. Food and Drug Administration (FDA) and other regulatory agencies around the world rely on clinical trial data to provide evidence that a therapy will work safely and effectively in a large number of patients.
Patient participation in clinical trials is important. For a listing of clinical trials that may be enrolling patients, please visit ClinicalTrials.gov.
At Dermira, we are focused on serving unmet needs in medical dermatology, conducting clinical trials aimed at gaining regulatory approval, and making products available to patients as quickly as possible. We understand the interest of patients in accessing approved and unapproved Dermira products outside of clinical trials, however we do not currently offer any Expanded Access programs.
As such, we believe participation in our clinical trials is the most appropriate way to access Dermira’s investigational drug, lebrikizumab, at this stage of development.
Information about our clinical trials, including eligibility criteria and locations, is available at ClinicalTrials.gov.
We recognize the need for Expanded Access programs and will re-evaluate the status of our policy based on data from ongoing and future clinical trials.