Expanded Access Policy
Sinovent’s Expanded Access Policy to XNW4107
Sinovent is to develop XNW4107 in combination with imipenem/cilastatin for the treatment of patients with infection caused by resistant pathogens including carbapenem-resistant Enterobacteriaceae (CRE), carbapenem-resistant A. baumannii (CRAB) and multidrug resistant (MDR) P. aeruginosa. XNW4107 has been granted the fast-track designation by the U.S. Food and Drug Administration (FDA).
An expanded access policy, also known as compassionate use, allows investigational medical products that have not yet been approved or cleared by the U.S. Food and Drug Administration to be provided to patients with immediately life-threatening conditions or serious diseases when treatment within a clinical trial or comparable or satisfactory alternative therapy options are not available.
We understand that expanded access to our investigational product XNW4107 may be needed in certain patients prior to FDA approval. With a careful review to expanded access, Sinovent has determined that it cannot offer XNW4107 for expanded access at this time, since XNW4107 itself has no antimicrobial activities, and more clinical data of safety and efficacy for XNW4107 in combination with imipenem/cilastatin need to be generated to determine whether XNW4107 will benefit to patients with serious infections.
If you or a family member would like to learn more about Sinovent’s clinical trials, we encourage you to work with your physician to see if you are a candidate for our clinical trials. You may also find helpful information regarding Sinovent’s clinical trials by visiting www.clinicaltrials.gov.
If you have questions about Sinovent’s expanded access policy, please email us at email@example.com.