Lycera’s mission is to develop and advance new classes of therapeutics that can selectively suppress or activate the immune system, with the potential to transform the treatment and outcomes for patients suffering from serious immune-related diseases.
The first step in advancing Lycera’s investigational new drugs is to conduct clinical trials which will assess the safety and efficacy of the products. After adequate safety and efficacy data are collected, Lycera plans to submit applications to the FDA and other Regulatory Agencies in order to obtain marketing approval. Only after the FDA and other Regulatory Authorities grant approval can Lycera provide patients broad access to these products.
The FDA and other Regulatory Agencies will only grant approval for a new drug if these clinical studies demonstrate that the investigational new drug has a favorable risk/benefit profile.
What is expanded access?
Through expanded access (also called compassionate use), drug manufacturers obtain permission from the FDA to make investigational products not yet approved by FDA available to patients with serious or life-threatening conditions outside of a traditional clinical trial setting.
Lycera is completing clinical studies to understand each of the investigational new drug’s efficacy and side effect profile. Until the efficacy and safety profile as well as dosing regimen are fully understood, Lycera must exercise due care in authorizing expanded access. Lycera believes that participation in clinical trials is the best way for patients to obtain access to Lycera’s investigational new drugs before they are approved by the FDA and other Regulatory Agencies.
There may be occasions when it is not possible for patients to participate in a clinical trial. In these cases, and where patients have serious or life-threatening conditions with no satisfactory alternative treatment options, expanded access to Lycera’s investigational new drugs may be requested. The expanded access request must be made by the patient’s healthcare professional who is responsible for overseeing the patient’s treatment.
For more information on clinical trials, see https://clinicaltrials.gov. Search “Lycera” to find Lycera clinical trials that may currently be recruiting.
How is expanded access requested?
- Procedure: All requests for expanded access to Lycera’s investigational drug products must be made by the patient’s healthcare provider (i.e., physician) via electronic submission through email@example.com. The physician must be licensed in the country where the patient resides.
- Contact Information: If you are a healthcare professional and would like to request expanded access use of a Lycera investigational medicine, please send an email to firstname.lastname@example.org. The following information must be included in the request:
- Investigational medicine being requested
- Contact details for healthcare professional (address, email address, telephone, medical license number)
- Do not include any personally identifiable patient information in the request
- Timeline: Lycera anticipates acknowledging receipt of expanded access requests within 3-5 business days. Lycera will consider all expanded access requests in a fair and timely manner.
How is an expanded access request evaluated?
Expanded access requests will be considered on a case-by-case basis. Lycera will take into consideration a number of criteria when evaluating an expanded access request, including, but not necessarily limited to:
- Whether the patient has a serious or life-threatening disease or condition;
- Whether there are alternative therapies available that would be comparable or satisfactory;
- Whether the patient suffers from a disease or condition that is sufficiently similar to the disease or condition for which a clinical trial is being conducted;
- Whether the patient is ineligible or unable to participate in an ongoing clinical trial;
- Whether the investigational product is currently being studied in humans;
- Whether providing the investigational product on an expanded access basis will interfere with the conduct of clinical trials or any regulatory submissions;
- Whether there are sufficient data to show that the potential benefits of the drug outweigh the possible risks;
- Whether Lycera plans to pursue regulatory approval for the product in the patient’s country; and/or
- Whether an adequate supply of the investigational drug is available.
Because the circumstances of each request are different, there is no guarantee that an expanded access request will be granted for any specific investigational drug. This policy is subject to change at the discretion of Lycera.
This policy only covers expanded access requests for individual patients. Any requests for a treatment-related investigational new drug application (IND), treatment protocol(s), or Investigator-Initiated trial(s), which would cover larger groups of patients and necessitate a new clinical study for one of Lycera’s investigational drugs are outside the scope of this expanded access policy and will be evaluated separately by Lycera Medical Affairs.