RC18 (telitacicept) for primary Sjögren’s syndrome
The following criteria are typically required before RemeGen would consider patients eligible for expanded access to a RemeGen investigational product. All criteria are subject to local laws and regulations.
• The patient suffers from a life threatening or serious disease or condition, where there is an unmet medical need that cannot be met by existing products.
• The patient is ineligible or unable to participate in any ongoing clinical study of the investigational product.
• The investigational product is under active development (a dose and regimen has been defined and the product is typically in Phase 2 development or beyond) and has not been placed on regulatory or any other hold.
• The benefit-risk profile of the drug in the indication and the patient population is deemed, to date, to be positive which typically occurs when RemeGen has decided to seek marketing approval in at least one major market globally.
• RemeGen has decided to seek marketing approval in at least one major market globally.
• The expanded access use of the investigational product will not jeopardize the development of the drug (for instance, granting access to an investigational unapproved drug through expanded access should not delay, interfere with, or compromise the completion of clinical trials that are intended to support approval by regulatory authorities).
• The use of the investigational product in an expanded access protocol is compliant with local rules and regulations.
RemeGen cannot approve expanded access use requests in cases where doing so would violate company policy, local laws or regulations, or if access would present an unacceptable benefit/risk profile, as deemed by medical personnel of the company.
We commit to a careful and fair evaluation of each request by the appropriate medical experts at RemeGen within the boundaries of local laws and regulations. All requests for expanded access (typically made by the treating physician) will be acknowledged by medical personnel from RemeGen (or our agent) within 7 business days. Should the request be approved, the requestor must enter into an Expanded Access Agreement with RemeGen.